Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

NCT01823237 | Suspended

• 2 other identifiers: IRB00062538DYST
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Keywords

Dystonia; Transcranial Magnetic Stimulation; Rehabilitation; Plasticity

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

rTMS

ACTIVE COMPARATOR

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

Device: Transcranial Magnetic Stimulation

rTMS sham

PLACEBO COMPARATOR

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

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Also known as: TMS

rTMS; rTMS sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Dystonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Cathrin Buetefisch, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 4, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

US (1)