NCT02504905

Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing

Completed EARLY_PHASE1 Last updated 5 March 2025

What this trial tests

EARLY_PHASE1 trial testing TMS in Writer's Cramp in 58 participants. Completed in 25 July 2021.

Timeline

20 August 2015

Primary endpoint
25 July 2021

25 July 2021

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	basic science
Enrollment	58
Start date	20 August 2015
Primary completion	25 July 2021
Estimated completion	25 July 2021
Sites	1 location across United States

Drugs / interventions tested

• TMS — full drug profile →

Conditions studied

• Writer's Cramp — all drugs for Writer's Cramp →
• Healthy Volunteers — all drugs for Healthy Volunteers →
• Cervical Dystonia — all drugs for Cervical Dystonia →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 65, any sex, with Writer's Cramp or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People with dystonia have muscle contractions they can t control. These cause slow, repeated motions or abnormal postures. People with dystonia have abnormalities in certain parts of the brain. Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia.

Objective:

\- To compare brain activity in people with dystonia to that in healthy people.

Eligibility:

* Right-handed people ages of 18-65 with cervical dystonia or writer s cramp.
* Healthy volunteers the same ages.

Design:

* Participants will be screened with a physical exam. They will answer questions about being right- or left-handed.
* At study visit 1, participants will:\<TAB\>
* Have a neurological exam.
* Answer questions about how their disease impacts their daily activities.
* Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a table that can slide \<TAB\>in and out of a metal cylinder. This is surrounded by a strong magnetic field.
* Do 2 simple computer tasks.
* At study visit 2:
* Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head. Two wire coils will be held on the scalp. A brief electrical current creates a magnetic pulse that affects brain activity. Muscles of the face, arm, or leg might twitch. Participants may have to tense certain muscles or do simple tasks during TMS. They may be asked to rate any discomfort caused by TMS.
* Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.