Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Primary Purpose
Dystonia
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Dystonia focused on measuring Dystonia, Transcranial Magnetic Stimulation, Rehabilitation, Plasticity
Eligibility Criteria
Inclusion Criteria:
- If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
- Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
- No dystonic movements at rest
- Normal MRI scan of the brain as per clinical record
- No intake of CNS active drugs that may interfere with the study
- No contraindication for TMS
- Ability to perform the selective task
- No other neurological disease that may interfere with the study
- Ability to give informed consent
Exclusion Criteria:
- You have a history of migraines
- You have a diagnosed seizure disorder
- You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
- You have any clips or implants in your head
- You have a pacemaker
Sites / Locations
- Emory University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
rTMS
rTMS sham
Arm Description
rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity
Placebo condition will use a sham coil and apply a very small magnetic stimulus
Outcomes
Primary Outcome Measures
Efficacy of TMS on task-specific focal hand dystonia
We will assess the effects of rTMS using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01823237
Brief Title
Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Official Title
Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Study is temporarily suspended pending additional funding to continue subject recruitment.
Study Start Date
February 2013 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dystonia is a disease where muscles in the affected body part are abnormally active. This may result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism is located in the motor area of the brain that controls the coordination of muscles, called the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite side of the body. When people perform tasks such as picking up an object or writing there are mechanisms in motor cortex that focus the level of activity so that they can do these tasks with a high level of precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When applied to the motor cortex it can upregulate or down regulate its activity. In the present study the investigators will conduct experiments on subjects with task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The investigators will assess the effects of this intervention using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia
Keywords
Dystonia, Transcranial Magnetic Stimulation, Rehabilitation, Plasticity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Active Comparator
Arm Description
rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity
Arm Title
rTMS sham
Arm Type
Placebo Comparator
Arm Description
Placebo condition will use a sham coil and apply a very small magnetic stimulus
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Primary Outcome Measure Information:
Title
Efficacy of TMS on task-specific focal hand dystonia
Description
We will assess the effects of rTMS using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.
Time Frame
Up to 3 weeks (2 visits)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
No dystonic movements at rest
Normal MRI scan of the brain as per clinical record
No intake of CNS active drugs that may interfere with the study
No contraindication for TMS
Ability to perform the selective task
No other neurological disease that may interfere with the study
Ability to give informed consent
Exclusion Criteria:
You have a history of migraines
You have a diagnosed seizure disorder
You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
You have any clips or implants in your head
You have a pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathrin Buetefisch, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
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Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
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