Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT01823237

Collaborator

(none)

Enrollment

Location

Arms

124.9

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dystonia	Device: Transcranial Magnetic Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Actual Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rTMS rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity	Device: Transcranial Magnetic Stimulation Other Names: TMS
Placebo Comparator: rTMS sham Placebo condition will use a sham coil and apply a very small magnetic stimulus	Device: Transcranial Magnetic Stimulation Other Names: TMS

Arm

Intervention/Treatment

Active Comparator: rTMS

rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity

Device: Transcranial Magnetic Stimulation

Other Names:

TMS

Placebo Comparator: rTMS sham

Placebo condition will use a sham coil and apply a very small magnetic stimulus

Device: Transcranial Magnetic Stimulation

Other Names:

TMS

Outcome Measures

Primary Outcome Measures

Efficacy of TMS on task-specific focal hand dystonia [Up to 3 weeks (2 visits)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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