Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

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.

Study Overview

• Status: Suspended
• Conditions: Dystonia
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Farrah E Rink, MHSc; Phone Number: 678-369-3152; Email: frink@emory.edu
• Study Contact Backup: Name: Cathrin Buetefisch, MD, PhD; Phone Number: 404-712-1894; Email: cbuetefisch@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 weeks (2 visits)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Cathrin Buetefisch, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimated): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Transcranial Magnetic Stimulation; Plasticity; Dystonia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: IRB00062538; DYST (Other Identifier: Other)