Essential Tremor
Conditions
Brief summary
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.
Interventions
DEVICECala ONE Device
The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Sponsors
Cala Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 22 years or older 2. A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist 3. Signed informed consent 4. At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person. 5. Score of 3 or above in any one of the items of the Bain & Findley ADL Scale
Exclusion criteria
1. Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator 2. Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor 3. Suspected or diagnosed epilepsy or other seizure disorder 4. Pregnant 5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site 6. Peripheral neuropathy affecting the tested upper extremity 7. Alcoholism (score of 4 or higher on DSM-5) 8. Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia 9. Other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration 10. Changes in medication for tremor within 1 month prior to study enrollment 11. Change in antidepressant medication within 3 months prior to study enrollment 12. Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment 13. Current participation in any other interventional research study 14. Previous participation in any other Cala Health interventional research study 15. Alcohol or caffeine consumption within 12 hours of study enrollment Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TETRAS Spiral Rating After Stimulation | Immediately before and after 40 minute stimulation session | The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TETRAS Spiral Rating During Stimulation | Immediately before and 30 minutes into stimulation session | An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
| Self-report Improvement | Immediately before and after 40 minute stimulation session | The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | Immediately before and after 40 minute stimulation session | The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Bain & Findley ADL: Hold a Cup of Liquid | Immediately before and after 40 minute stimulation session | The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Bain & Findley ADL: Pouring | Immediately before and after 40 minute stimulation session | The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Kinetic Tremor | Immediately before and after 40 minute stimulation session | The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
| Change in Bain & Findley ADL: Picking up Change | Immediately before and after 40 minute stimulation session | The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Bain & Findley ADL: Inserting Plug Into Socket | Immediately before and after 40 minute stimulation session | The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Bain & Findley ADL: Unlocking | Immediately before and after 40 minute stimulation session | The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Bain & Findley ADL: Dialing | Immediately before and after 40 minute stimulation session | The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. |
| Change in Lateral Wing Beating Postural Tremor | Immediately before and after 40 minute stimulation session | The change in tremor severity in the lateral wing beating postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
| Change in Forward Outstretched Postural Tremor | Immediately before and after 40 minute stimulation session | The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAPS Stimulation Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. | 48 |
| Sham Stimulation 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. | 45 |
| Total | 93 |
Baseline characteristics
| Characteristic | TAPS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 33 Participants | 69 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 70.5 years STANDARD_DEVIATION 11.2 | 69.8 years STANDARD_DEVIATION 10.1 | 70.2 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 45 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 41 Participants | 88 Participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 23 Participants | 22 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 48 | 1 / 45 |
| serious Total, serious adverse events | 0 / 48 | 0 / 45 |
Outcome results
Primary
Change in TETRAS Spiral Rating After Stimulation
The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in TETRAS Spiral Rating After Stimulation | Baseline | 2.95 score on a scale | Standard Deviation 0.68 |
| TAPS Stimulation | Change in TETRAS Spiral Rating After Stimulation | Post Stimulation | 2.41 score on a scale | Standard Deviation 1 |
| Sham Stimulation | Change in TETRAS Spiral Rating After Stimulation | Baseline | 2.63 score on a scale | Standard Deviation 0.52 |
| Sham Stimulation | Change in TETRAS Spiral Rating After Stimulation | Post Stimulation | 2.23 score on a scale | Standard Deviation 0.8 |
Secondary
Change in TETRAS Spiral Rating During Stimulation
An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and 30 minutes into stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in TETRAS Spiral Rating During Stimulation | Baseline | 2.95 score on a scale | Standard Deviation 0.68 |
| TAPS Stimulation | Change in TETRAS Spiral Rating During Stimulation | During Stimulation | 2.58 score on a scale | Standard Deviation 0.9 |
| Sham Stimulation | Change in TETRAS Spiral Rating During Stimulation | Baseline | 2.63 score on a scale | Standard Deviation 0.52 |
| Sham Stimulation | Change in TETRAS Spiral Rating During Stimulation | During Stimulation | 2.26 score on a scale | Standard Deviation 0.67 |
Secondary
Self-report Improvement
The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse).
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAPS Stimulation | Self-report Improvement | 35 Participants |
| Sham Stimulation | Self-report Improvement | 23 Participants |
Other Pre-specified
Change in Bain & Findley ADL: Dialing
The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Dialing | Baseline | 2.23 score on a scale | Standard Deviation 0.89 |
| TAPS Stimulation | Change in Bain & Findley ADL: Dialing | Change after stimulation | -0.70 score on a scale | Standard Deviation 0.79 |
| Sham Stimulation | Change in Bain & Findley ADL: Dialing | Baseline | 2.00 score on a scale | Standard Deviation 0.91 |
| Sham Stimulation | Change in Bain & Findley ADL: Dialing | Change after stimulation | -0.30 score on a scale | Standard Deviation 0.62 |
Other Pre-specified
Change in Bain & Findley ADL: Hold a Cup of Liquid
The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Hold a Cup of Liquid | Baseline | 2.95 score on a scale | Standard Deviation 0.85 |
| TAPS Stimulation | Change in Bain & Findley ADL: Hold a Cup of Liquid | Change after stimulation | -1.03 score on a scale | Standard Deviation 0.73 |
| Sham Stimulation | Change in Bain & Findley ADL: Hold a Cup of Liquid | Baseline | 2.65 score on a scale | Standard Deviation 0.92 |
| Sham Stimulation | Change in Bain & Findley ADL: Hold a Cup of Liquid | Change after stimulation | -0.57 score on a scale | Standard Deviation 0.8 |
Other Pre-specified
Change in Bain & Findley ADL: Inserting Plug Into Socket
The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Inserting Plug Into Socket | Change after stimulation | -0.33 score on a scale | Standard Deviation 0.69 |
| TAPS Stimulation | Change in Bain & Findley ADL: Inserting Plug Into Socket | Baseline | 1.83 score on a scale | Standard Deviation 0.78 |
| Sham Stimulation | Change in Bain & Findley ADL: Inserting Plug Into Socket | Baseline | 1.76 score on a scale | Standard Deviation 0.8 |
| Sham Stimulation | Change in Bain & Findley ADL: Inserting Plug Into Socket | Change after stimulation | -0.24 score on a scale | Standard Deviation 0.55 |
Other Pre-specified
Change in Bain & Findley ADL: Picking up Change
The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Picking up Change | Baseline | 2.03 score on a scale | Standard Deviation 0.86 |
| TAPS Stimulation | Change in Bain & Findley ADL: Picking up Change | Change after stimulation | -0.53 score on a scale | Standard Deviation 0.68 |
| Sham Stimulation | Change in Bain & Findley ADL: Picking up Change | Baseline | 1.92 score on a scale | Standard Deviation 0.89 |
| Sham Stimulation | Change in Bain & Findley ADL: Picking up Change | Change after stimulation | -0.05 score on a scale | Standard Deviation 0.62 |
Other Pre-specified
Change in Bain & Findley ADL: Pouring
The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Pouring | Change after stimulation | -0.70 score on a scale | Standard Deviation 0.76 |
| TAPS Stimulation | Change in Bain & Findley ADL: Pouring | Baseline | 2.78 score on a scale | Standard Deviation 1.03 |
| Sham Stimulation | Change in Bain & Findley ADL: Pouring | Change after stimulation | -0.59 score on a scale | Standard Deviation 0.72 |
| Sham Stimulation | Change in Bain & Findley ADL: Pouring | Baseline | 2.59 score on a scale | Standard Deviation 0.86 |
Other Pre-specified
Change in Bain & Findley ADL: Unlocking
The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Unlocking | Baseline | 2.23 score on a scale | Standard Deviation 0.86 |
| TAPS Stimulation | Change in Bain & Findley ADL: Unlocking | Change after stimulation | -0.60 score on a scale | Standard Deviation 0.87 |
| Sham Stimulation | Change in Bain & Findley ADL: Unlocking | Baseline | 1.86 score on a scale | Standard Deviation 0.67 |
| Sham Stimulation | Change in Bain & Findley ADL: Unlocking | Change after stimulation | -0.16 score on a scale | Standard Deviation 0.55 |
Other Pre-specified
Change in Bain & Findley ADL: Use a Spoon to Drink Liquid
The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | Baseline | 3.18 score on a scale | Standard Deviation 0.78 |
| TAPS Stimulation | Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | Change after stimulation | -0.78 score on a scale | Standard Deviation 0.89 |
| Sham Stimulation | Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | Baseline | 3.00 score on a scale | Standard Deviation 0.85 |
| Sham Stimulation | Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | Change after stimulation | -0.59 score on a scale | Standard Deviation 0.76 |
Other Pre-specified
Change in Forward Outstretched Postural Tremor
The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Forward Outstretched Postural Tremor | Baseline | 1.96 score on a scale | Standard Deviation 0.54 |
| TAPS Stimulation | Change in Forward Outstretched Postural Tremor | Change after stimulation | -0.75 score on a scale | Standard Deviation 0.65 |
| Sham Stimulation | Change in Forward Outstretched Postural Tremor | Baseline | 1.91 score on a scale | Standard Deviation 0.54 |
| Sham Stimulation | Change in Forward Outstretched Postural Tremor | Change after stimulation | -0.35 score on a scale | Standard Deviation 0.51 |
Other Pre-specified
Change in Forward Outstretched Postural Tremor
The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and 30 minutes into stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Forward Outstretched Postural Tremor | Baseline | 1.96 score on a scale | Standard Deviation 0.54 |
| TAPS Stimulation | Change in Forward Outstretched Postural Tremor | Change during stimulation | -0.56 score on a scale | Standard Deviation 0.59 |
| Sham Stimulation | Change in Forward Outstretched Postural Tremor | Baseline | 1.91 score on a scale | Standard Deviation 0.54 |
| Sham Stimulation | Change in Forward Outstretched Postural Tremor | Change during stimulation | -0.35 score on a scale | Standard Deviation 0.41 |
Other Pre-specified
Change in Kinetic Tremor
The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and 30 minutes into stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Kinetic Tremor | Baseline | 2.29 score on a scale | Standard Deviation 0.47 |
| TAPS Stimulation | Change in Kinetic Tremor | Change during stimulation | -0.50 score on a scale | Standard Deviation 0.51 |
| Sham Stimulation | Change in Kinetic Tremor | Baseline | 2.27 score on a scale | Standard Deviation 0.47 |
| Sham Stimulation | Change in Kinetic Tremor | Change during stimulation | -0.53 score on a scale | Standard Deviation 0.59 |
Other Pre-specified
Change in Kinetic Tremor
The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Kinetic Tremor | Baseline | 2.29 score on a scale | Standard Deviation 0.47 |
| TAPS Stimulation | Change in Kinetic Tremor | Change after stimulation | -0.53 score on a scale | Standard Deviation 0.59 |
| Sham Stimulation | Change in Kinetic Tremor | Change after stimulation | -0.34 score on a scale | Standard Deviation 0.43 |
| Sham Stimulation | Change in Kinetic Tremor | Baseline | 2.27 score on a scale | Standard Deviation 0.47 |
Other Pre-specified
Change in Lateral Wing Beating Postural Tremor
The change in tremor severity in the lateral wing beating postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and 30 minutes into stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Lateral Wing Beating Postural Tremor | Baseline | 2.29 score on a scale | Standard Deviation 0.7 |
| TAPS Stimulation | Change in Lateral Wing Beating Postural Tremor | Change during stimulation | -0.51 score on a scale | Standard Deviation 0.7 |
| Sham Stimulation | Change in Lateral Wing Beating Postural Tremor | Baseline | 2.16 score on a scale | Standard Deviation 0.57 |
| Sham Stimulation | Change in Lateral Wing Beating Postural Tremor | Change during stimulation | -0.34 score on a scale | Standard Deviation 0.44 |
Other Pre-specified
Change in Lateral Wing Beating Postural Tremor
The change in tremor severity in the lateral wing beating postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time frame: Immediately before and after 40 minute stimulation session
Population: Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAPS Stimulation | Change in Lateral Wing Beating Postural Tremor | Change after stimulation | -0.56 score on a scale | Standard Deviation 0.72 |
| TAPS Stimulation | Change in Lateral Wing Beating Postural Tremor | Baseline | 2.29 score on a scale | Standard Deviation 0.7 |
| Sham Stimulation | Change in Lateral Wing Beating Postural Tremor | Baseline | 2.16 score on a scale | Standard Deviation 0.57 |
| Sham Stimulation | Change in Lateral Wing Beating Postural Tremor | Change after stimulation | -0.36 score on a scale | Standard Deviation 0.54 |