Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor (NCT NCT04299087)

Last Updated: 2023-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Day 1

Results posted on

2023-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	11	1
Overall Study COMPLETED	9	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dystonia and/or Tremor n=11 Participants 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.	Control n=1 Participants 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	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	63.583 years STANDARD_DEVIATION 11.172 • n=5 Participants	66 years STANDARD_DEVIATION 0 • n=7 Participants	63.583 years STANDARD_DEVIATION 11.172 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	1 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Dystonia and/or Tremor n=11 Participants 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.	Control n=1 Participants 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
Cognitive Assessment Using MoCA Version 7.1 Scores	25.45 units on a scale Standard Deviation 3.78	27 units on a scale Standard Deviation 0

Adverse Events

Dystonia and/or Tremor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Vaillancourt

University of Florida

Phone: (352) 294 - 1770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place