Dystonia, Tremor
Conditions
Brief summary
The study will include subjects diagnosed with Dystonic Tremor (DT), Essential Tremor (ET), and healthy controls in the age range of 21-80 years. Electroencephalography (EEG) will be used as the primary outcome measure. Transcranial Magnetic Stimulation (TMS) will be used over the motor cortices or cerebellar cortices as an intervention that is expected to have short-term (less than an hour) electrophysiological effects.
Detailed description
The primary goal of this study is to compare differences in cortical activity of patients with tremor before and after applying a session of rTMS. Specifically, the investigators will apply rTMS to the primary motor cortex (M1) as our group and others have shown abnormal function of the region. Moreover, a study shows that targeting of M1 and the dorsal premotor cortex (dPMC) with rTMS results in a trend towards improved clinical outcome in patients with focal hand dystonia and cervical dystonia. The central hypothesis of this study is that rTMS can modify cortical oscillations in patient populations with tremor and that the investigators will be able to detect these changes with the use of Electroencephalography (EEG). By applying inhibitory rTMS to the motor cortices, the investigators may expect a shift in cortical oscillations towards normal activity.
Interventions
DEVICErepetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.
OTHERControl group
No application of rTMS
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
for Dystonia and/or tremor: \- Diagnosis of Dystonia and/or tremor according to the Consensus Statement of the Movement Disorders Society
Exclusion criteria
Dystonia and/or tremor: * Pregnancy * Active seizure disorder * Presence of a metallic object such as a pacemaker, implants, metal rods, and hearing aid * History of stroke Inclusion Criteria for Healthy controls \- There is no history of any neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Assessment Using MoCA Version 7.1 Scores | Day 1 | Montreal Cognitive Assessment Version 7.1 was used to assess cognitive ability. This scales is score from a range of 0 to 30 with a score of 24 or less indicating mild cognitive impairment. Moderate cognitive impairment is indicated by a score of 18-23 and severe impairment is a score of 10 or less. Overall, a higher number indicates better cognitive ability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dystonia and/or Tremor Adults with a diagnosis of dystonia and/or tremor
repetitive Transcranial Magnetic Stimulation (rTMS): Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain. | 11 |
| Control Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group
Control group: No application of rTMS | 1 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Dystonia and/or Tremor |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 7 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 5 Participants | 4 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 0 | 63.583 years STANDARD_DEVIATION 11.172 | 63.583 years STANDARD_DEVIATION 11.172 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 1 Participants | 12 Participants | 11 Participants |
| Region of Enrollment United States | 1 participants | 12 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 1 |
| other Total, other adverse events | 0 / 11 | 0 / 1 |
| serious Total, serious adverse events | 0 / 11 | 0 / 1 |
Outcome results
Primary
Cognitive Assessment Using MoCA Version 7.1 Scores
Montreal Cognitive Assessment Version 7.1 was used to assess cognitive ability. This scales is score from a range of 0 to 30 with a score of 24 or less indicating mild cognitive impairment. Moderate cognitive impairment is indicated by a score of 18-23 and severe impairment is a score of 10 or less. Overall, a higher number indicates better cognitive ability.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dystonia and/or Tremor | Cognitive Assessment Using MoCA Version 7.1 Scores | 25.45 units on a scale | Standard Deviation 3.78 |
| Control | Cognitive Assessment Using MoCA Version 7.1 Scores | 27 units on a scale | Standard Deviation 0 |