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

NCT02504905 | Completed Early Phase 1

• 2 other identifiers: 15016715-N-0167
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Writer's Cramp; Healthy Volunteers; Cervical Dystonia

Keywords

Parietal Lobe; Plasticity; Dystonia; Transcranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (1)

• MEP size at S50 with respect to time (before, and 15-20 min after PAS intervention)

  The size of the MEP in the EMG signal gives information about corticospinal excitability as a function of TMS stimulation. An increase in average MEP after the end of PAS intervention implies development of LTP-like plasticity in the pathway linking the parietal cortex or the cerebellum to M1. A decrease would imply development of LTD-like plasticity.

  throughout

Study Arms (2)

PAR-CD

EXPERIMENTAL

CD and age/sex matched HV control

Device: TMS

PAR-WC

EXPERIMENTAL

WC and age/sex matched HV control

Device: TMS

Interventions

TMS DEVICE

single TMS pulses at intensities in random order from 0 to 100% (increasing at 5% intervals) of stimulator output at a frequency of 0.1 Hz. Three pulses will be delivered at each intensity. MEPs will be recorded and their amplitudes will be plotted against the corresponding stimulation intensity. This curve will provide three significant parameters: (a) S50 intensity (intensity for which we get a MEP 50 % of its maximal size); (b) estimated resting motor threshold (RMT): the abscissa where the tangent to the slope crosses the x axis; and (c) the maximum MEP ( plateau value).

PAR-CD; PAR-WC

Eligibility Criteria

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

You may qualify if:

• Between the ages of 18 and 65 years
• Right-handed
• English speaking
• For patients only: confirmed diagnosis of cervical dystonia (PAR-CD) or writer s cramp (PAR-WC).
• For patients treated with anticholinergics and/or benzodiazepines, they must be willing and safely able to abstain from any of these medication for a period of at least 5 plasma half-lives of the individual drug prior to study participation (2 days for trihexyphenidyl which has a plasma half life around 4 hours; 12 days, for clonazepam which has a half-life of 18-50 hours).
• For HVs only: absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
• Ability to give informed consent
• Ability to comply with all study procedures, based on the judgment by the investigator(s).

You may not qualify if:

• Any of the following will exclude patients from the study:
• Secondary forms of dystonia, including tardive dyskinesia.
• Dystonic tremor where the tremor is the sole or principal abnormality.
• Botulinum toxin treatment \< 3 months prior to visit.
• Any of the following will exclude patients or healthy controls from the study:
• Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
• Self-reported consumption of 7 alcoholic drinks a week for women and \>14 alcoholic drinks a week for man.
• Abnormal findings on neurologic exam (other than dystonia in patient group).
• History of or current brain tumor, stroke, head trauma with loss of consciousness \> few seconds, epilepsy or seizures.
• Current diagnosis of major depression or any major mental disorders (axis I disorders).
• Current diagnosis of neurologic disorder other than dystonia.
• Presence of pacemaker, intracardiac lines, implanted pumps or stimulators, or metal objects inside the eye or skull. Dental fillings and dental braces are allowed.
• Known hearing loss.
• Open scalp wounds or scalp infection.
• Current pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dystonic Disorders; Torticollis; Dystonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyun Joo Cho, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: August 20, 2015
• Primary Completion: July 25, 2021
• Study Completion: July 25, 2021
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

US (1)