Physiological Investigations of Movement Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01019343
First received: November 24, 2009
Last updated: July 3, 2014
Last verified: January 2014
  Purpose

Background:

  • Previous studies have given researchers information on how the brain controls movement, how people learn to make fine, skilled movements, and why some people have movement disorders. However, further research is needed to learn more about the causes of most movement disorders, such as Parkinson's disease.
  • By using small, specialized studies to evaluate people with movement disorders and compare them with healthy volunteers, researchers hope to learn more about the changes in the brain and possible causes of movement disorders.

Objectives:

  • To better understand how the brain controls movement.
  • To learn more about movement disorders.
  • To train movement disorder specialists.

Eligibility:

  • Individuals 18 years of age or older who have had a movement disorder diagnosed by a neurologist and are able to participate based on the specific requirements of the small study.
  • Healthy volunteers 18 years of age or older.

Design:

  • Participants will have a screening visit with medical history, physical examination, and questionnaire to determine eligibility. Eligible participants will give consent to participate in up to seven additional outpatient visits for study procedures. The number of sessions and the procedures needed for participation depend on specific symptoms.
  • Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea) for at least 2 days (48 hours) before each session.
  • Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI scans, electroencephalography, magnetoencephalography, transcranial magnetic stimulation, nerve and sensory stimulation, or movement and mental tasks during any of the above procedures.
  • This study does not provide treatment for movement disorders. Participants will not have to stop any treatment in order to participate.

Condition
Parkinson's Disease
Tourette's Syndrome
Tic Disorders
Dystonia
Movement Disorders

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Physiological Investigations of Movement Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • MRI Signals, EEG/MEG signals, Ampitude of muscle potentials (MEP) evocked by TMS.

Estimated Enrollment: 1050
Study Start Date: October 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

INCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:

  • Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the sub-study
  • Age 18 or older
  • Able to give informed consent
  • Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents can modify brain activity and may confound outcome measures.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

  • Age 18 or older.
  • Able to give informed consent.
  • Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents may modify the activity of the brain during the study.

EXCLUSION CRITERIA:

EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:

  • Have used illegal drugs within the past 6 months
  • Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man.
  • Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
  • Have a psychotic disorder, Bipolar Disorder or a current depressive episode.
  • Have another neurologic disorder than a movement disorder
  • Have had a head injury where there was a loss of consciousness for more than a few seconds.

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

  • Have abnormal findings on a neurological examination that we will perform
  • Have used illegal drugs within the past 6 months
  • Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
  • Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
  • Have major depression or any major mental disorders (axis I disorders)
  • Have a neurological disorder.
  • Have had a head injury where there was a loss of consciousness for more than a few seconds.

ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR fMRI:

We will follow the NMR Center guidelines for MR safety.

Some of the exclusions are:

  • Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
  • Unable to lie flat on the back for the expected length of the experiment up to 3 hours
  • Have uncontrolled movements of the head
  • Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis
  • Uncomfortable being in a small space for the expected length of the experiment up to 3 hours
  • Pregnancy

ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR TMS:

  • Have metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye, as these make TMS unsafe.
  • Have hearing loss.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019343

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01019343     History of Changes
Other Study ID Numbers: 100009, 10-N-0009
Study First Received: November 24, 2009
Last Updated: July 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Movement Disorder
Parkinson Disease
Tic Disorder
Magnetic Resonance Imaging (MRI)
Magnetoencephalogram
Electroencephalogram (EEG)
Transcranial Magnetic Stimulation (TMS)
Motor Deficit
Dystonia
PD
Tourette Syndrome
TS

Additional relevant MeSH terms:
Dystonic Disorders
Movement Disorders
Parkinson Disease
Tic Disorders
Nervous System Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Dystonia
Tics
Tourette Syndrome
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014