The Effects of Repetitive Paired Associative Stimulation in Dystonia

NCT01888926 | Completed

• 2 other identifiers: 13016313-N-0163
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- People with dystonia have serious muscle contractions that cause abnormal movements or postures. This significantly affects their daily lives. The common type is called organic. The other type is psychogenic. People with this type have typical symptoms plus some psychological effects. Researchers will look at how rapid transcranial magnetic stimulation (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect sensations. They will compare the responses of people with different types of dystonia. They will also compare the responses of people with dystonia to responses of people without it. This study may help us learn more about the nature of different types of dystonia. Objectives: \- To see whether TMS combined with nerve stimulation affects the brain differently in people with different types of dystonia and those without dystonia. Eligibility:

• Individuals at least 18 years old, who are right-handed and have dystonia.
• Healthy volunteers at least 18 years old. Design:
• Participants will have two clinical visits. Each visit will be a few hours long. They can be done on the same day.
• Participants will be screened with a medical history and physical exam.
• Participants will take several sensory tests. For these tests, electrodes will be placed on their skin. The participants will feel small electric shocks during some of the tests.
• Participants will undergo TMS. For 2 minutes, quick electrical currents will pass through a wire coil placed on their head. As this happens, researchers will ask the participants to move certain muscles.

Conditions

Dystonia

Keywords

rPAS; Dystonia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the motor evoked potential (MEP) amplitude at S50 after 30 minutes from rPAS (T30).

  30 minutes from rPAS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the organic dystonia group: Primary focal dystonia diagnosed or confirmed by a movement disorders neurologist, confirmed at the initial visit by a study investigator.
• For the psychogenic dystonia group: Clinically established psychogenic dystonia or probable psychogenic dystonia, according to the Fahn and Williams criteria confirmed by a movement disorders neurologist.
• For the healthy volunteers group: Age-matched healthy volunteers three will be age matched to pyschogenic dystonia group, and three will be age matched to organic dystonia group.
• Adult patients (at least18 years old).
• Right handed.
• Ability to provide own consent

You may not qualify if:

• Dystonia affecting the right APB and/or FDI, or inability of the subject to perform full range-of-motion exercises with the right FDI and/or APB.
• Medical condition impairing the subject's ability to comply with the study protocol as judged by study investigator, such as but not limited to seizures, brain tumor, stroke, bipolar disorder, depression, hearing problem, uncontrolled systemic hypertension with values above 170/100, heart disease or lung disease, active respiratory disease needing intervention; and pain preventing lying still for up to 40 minutes.
• Current or prior use of botulinum toxin within 3 months prior to TMS intervention.
• Current or prior use of CNS drugs (including antidepressants, anxiolytics, anticonvulsants, antipsychotics, anti-parkinsonian drugs, hypnotics, stimulants, and/or antihistamines) within 1 week prior to TMS intervention.
• Active drug or alcohol intake more than 7 alcohol drinks/week for women and more than 14 alcoholic drinks/week for men.
• Current pregnancy and lactating women. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at least 24 hours prior to TMS procedures.
• Presence of implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, history of shrapnel injury or any other condition/device that may be contraindicated
• Inability or unwillingness of subject to provide written informed consent.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Avanzino L, Martino D, van de Warrenburg BP, Schneider SA, Abbruzzese G, Defazio G, Schrag A, Bhatia KP, Rothwell JC. Cortical excitability is abnormal in patients with the "fixed dystonia" syndrome. Mov Disord. 2008 Apr 15;23(5):646-52. doi: 10.1002/mds.21801.

  PMID: 18175341 BACKGROUND

• Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.

  PMID: 14677378 BACKGROUND

• Cheeran B, Talelli P, Mori F, Koch G, Suppa A, Edwards M, Houlden H, Bhatia K, Greenwood R, Rothwell JC. A common polymorphism in the brain-derived neurotrophic factor gene (BDNF) modulates human cortical plasticity and the response to rTMS. J Physiol. 2008 Dec 1;586(23):5717-25. doi: 10.1113/jphysiol.2008.159905. Epub 2008 Oct 9.

  PMID: 18845611 BACKGROUND

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: June 18, 2013
• Primary Completion: August 2, 2016
• Study Completion: August 2, 2016
• Last Updated: February 14, 2018

Record last verified: 2016-08-02

Locations

US (1)