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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0167

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Writer's Cramp;
Healthly Volunteers;
Cervical Dystonia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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 60 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 <TAB>coils will be held on the scalp. A brief electrical current creates a magnetic pulse that affects brain <TAB>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.

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Eligibility

INCLUSION CRITERIA:

-Between the ages of 18 and 65 years

-Right-handed

-English speaking

-For patients only: confirmed diagnosis of cervical dystonia (CER-CD and PAR-CD studies) or writer s cramp (for CER-WC and PAR-WC studies).

-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).

EXCLUSION CRITERIA:

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.

-Taking benzodiazepines at the time of the study or within 12 days prior to the study.

-Taking anticholinergics at the time of the study or within 2 days prior to the study.

-Taking at the time of the study or within 2 weeks prior to the study any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, amphetamines, ketamine, gamma-hydroxybutyrate (GHB), theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, antihistamines, and sympathomimetics.


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Citations:

Hubsch C, Roze E, Popa T, Russo M, Balachandran A, Pradeep S, Mueller F, Brochard V, Quartarone A, Degos B, Vidailhet M, Kishore A, Meunier S. Defective cerebellar control of cortical plasticity in writer's cramp. Brain. 2013 Jul;136(Pt 7):2050-62. doi: 10.1093/brain/awt147.

Chao CC, Karabanov AN, Paine R, Carolina de Campos A, Kukke SN, Wu T, Wang H, Hallett M. Induction of motor associative plasticity in the posterior parietal cortex-primary motor network. Cereb Cortex. 2015 Feb;25(2):365-73. doi: 10.1093/cercor/bht230. Epub 2013 Aug 22.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02504905

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