Major Depressive Disorder
Conditions
Keywords
TMS, Major Depressive Disorder, NeuroStar TMS
Brief summary
The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.
Detailed description
This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.
Interventions
DEVICErepetitive Transcranial Magnetic Stimulation
the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function
Sponsors
Neuronetics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The study will be randomized to avoid any bias in treatment arm assignment. Subjects will be blinded to the actual treatment arm throughout the study to allow patient to provide an honest assessment of the treatment they are receiving daily. Subjects will not be informed of the treatment at the end of their study participation.
Intervention model description
Patients will be switched between different treatment arms and asked to complete questionnaires.
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. 22-70 years. * 2\. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician. 3\. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria. 4\. Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study. 6\. Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions. 7\. Subject provides written consent to take part in the study.
Exclusion criteria
* 1\. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI. 2\. Physician intends to treat the subject with an off-label TMS Therapy or indication. 3\. Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain. 6\. Known or suspected pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Comfort of TMS Treatment | 10 days | The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Prescribed Treatment Intensity | 5 days | Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled
repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Customized Mean Age | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Primary diagnosis | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 4 / 40 | 3 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Evaluate Comfort of TMS Treatment
The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain)
Time frame: 10 days
Population: VAS scores were collected for both standard and modified dash conditions for each participant. An average VAS score for each condition was calculated for each participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified DASH | Evaluate Comfort of TMS Treatment | 29.9 VAS score on a scale | Standard Deviation 18.4 |
| DASH | Evaluate Comfort of TMS Treatment | 29.3 VAS score on a scale | Standard Deviation 18 |
Secondary
Time to Reach Prescribed Treatment Intensity
Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT).
Time frame: 5 days
Population: Average time in number of days to reach maximum treatment intensity (120% MT). During the ramp-up phase, this could take 1-5 days in both arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified DASH | Time to Reach Prescribed Treatment Intensity | 1.78 days | Standard Deviation 1.28 |
| DASH | Time to Reach Prescribed Treatment Intensity | 1.9 days | Standard Deviation 1.05 |