Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Dystonia Clinical Trial

Official title:

Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01823237
• Other study ID #: IRB00062538
• Secondary ID: DYST
• Status: Suspended
• Phase: N/A
• Start date: February 2013
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)