Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
Primary Purpose
Dystonia, Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (rTMS)
Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Dystonia
Eligibility Criteria
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.
Exclusion Criteria for Healthy controls
- Pregnancy
- Any neurological disorders
- Presence of a metallic body in their brain
- History of stroke
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dystonia and/or tremor
Control
Arm Description
Adults with a diagnosis of dystonia and/or tremor
Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04299087
First Posted
February 28, 2020
Last Updated
August 15, 2023
Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT04299087
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
Official Title
Changes in Cortical Oscillations Induced by Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy in Patient Populations With Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Tremor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dystonia and/or tremor
Arm Type
Experimental
Arm Description
Adults with a diagnosis of dystonia and/or tremor
Arm Title
Control
Arm Type
Experimental
Arm Description
Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No application of rTMS
Primary Outcome Measure Information:
Title
Cognitive Assessment Using MoCA Version 7.1 Scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Exclusion Criteria for Healthy controls
Pregnancy
Any neurological disorders
Presence of a metallic body in their brain
History of stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vaillancourt, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
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