Physiological Investigations of Movement Disorders

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Brief Title

Physiological Investigations of Movement Disorders

Official Title

Physiological Investigations of Movement Disorders

Brief Summary

      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.
    

Detailed Description

      Objectives

      The purpose of this protocol is to improve understanding of the pathophysiology of movement
      disorders by performing small behavioral, electrophysiological and neuroimaging sub-studies.
      This will allow identifying dysfunction of the central nervous system that causes behavioral
      abnormalities seen in movement disorder patients. This will also help to determine potential
      diagnostic or therapeutic targets. Some sub-studies will require healthy volunteers. We will
      conduct:

        -  Pilot Sub-study (previously labeled as Small Pilot Sub-studies) Pilot sub-studies are
           exploratory in nature, in order to develop enough information to generate a hypothesis.
           The criterion for transition to a new full protocol will be a sufficient amount of
           information to generate a power analysis. There are no enrollment limitations for pilot
           sub-studies.Small substudies to pilot investigations for larger studies,

        -  Hypothesis-Testing Sub-study (previously labeled small number sSub-studies) is defined
           as a study with a specific hypothesis to be thattested that can be completed with a few
           subjects healthy volunteers or patients, , Hypothesis-testing sub-studies will undergo
           statistical and PIRC review after 6 subjects (if there is one group) or after 12 (six
           per arm) if two groups are studied before additional subjects are recruited. Together,
           the P.I. and PIRC will decide whether to continue the hypothesis sub-study with more
           subjects or if a new protocol is necessary. A memo requesting a review of
           hypothesis-testing sub-studies for possible additional enrollment will be sent to PIRC
           and the statistical reviewer. If the action to request accrual increase proceeds beyond
           PIRC to the IRB, then it needs to be submitted in the form of an amendment for
           prospective review/approval.

        -  Individual patient investigations that may increase knowledge of a disease process or be
           helpful in patient diagnosis,

        -  Training for investigators who do not have prior experience using electrophysiological
           and neuroimaging techniques,

        -  Technical development of new experimental paradigms.

      This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG,
      peripheral nerve stimulation, TMS).

      Study population

      We intend to study 1200 healthy volunteers and 1000 patients with diagnoses of movement
      disorders.

      Design

      We will design small projects as ideas arise in our patient population that are pertinent to
      the theme of movement disorder pathophysiology. We will investigate patients with movement
      disorders or healthy volunteers in the resting state or while they perform simple motor or
      sensory tasks. If a small study leads to results of interest and if a larger population is
      necessary to reach statistical significance, a separate protocol will be submitted with a
      priori hypotheses, specific study design and power analysis adapted from the pilot or
      exploratory sub-studies performed in the present protocol.

      Outcome measures

      MRI: we will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography
      between seed and target regions of interest (using DTI); morphometry of brain regions (using
      VBM); and different neurotransmitter levels in brain regions of interest (using MRS).

      EEG and MEG: we will quantify measures such as event- or task-related potentials,
      synchronization/desynchronization, and coherence between sensors or sources located close to
      the brain areas of interest.

      TMS: we will analyze measures such as MEP amplitude and central conduction time.

      Behavioral measures: we will quantify measures such as reaction times to initiate movements,
      EMG patterns, movement kinematics (position, velocity, acceleration, curvature).

      We may measure autonomic data during the course of the experiment (such as blood pressure,
      skin conductance, and respiratory rate) which would correlate to the outcome measures.
    


Study Type

Interventional


Primary Outcome

MRI


Condition

Parkinson's Disease

Intervention

Transcranial Direct Current Stimulation(tDCS)

Study Arms / Comparison Groups

 Healthy Volunteers
Description:  Healthy Volunteers

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1273

Start Date

December 8, 2009

Completion Date

October 9, 2020

Primary Completion Date

August 17, 2016

Eligibility 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 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 eye or skull area, brain stimulator, shrapnel, surgical metal, clips
             in the brain, cochlear implants, metal fragments in the eye, as these make TMS unsafe.
             Having a cardiac pacemaker, intracardiac lines, implanted pumps or stimulators are
             also exclusion criteria.

          -  Have hearing loss.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mark Hallett, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01019343

Organization ID

100009

Secondary IDs

10-N-0009

Responsible Party

Sponsor

Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

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


Verification Date

July 28, 2021