NIH Clinical Research Studies

Protocol Number: 02-N-0109

Active Accrual, Protocols Recruiting New Patients

Title:
Real-time Analysis of Scalp Electroencephalography and Magnetoencephalography During Production of Human Voluntary Movement
Number:
02-N-0109
Summary:
This study will use electroencephalography (EEG) to examine how the brain prepares for movement. It will look at 1) what changes occur in a person's brain just before voluntary movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the changes vary from person to person. The information from this study will be applied to other studies, such as exploring how brain changes that signal movement can be used to control prostheses in patients with spinal cord injuries or stroke.

Healthy normal volunteers 18 years of age and older may be eligible for this study. People with neurologic or psychiatric disorders and people taking medicines that may affect brain signals (e.g., Valium) may not participate.

Participants will come to the NIH Clinical Center on two separate days for testing sessions of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain signals, and electrodes will be placed on the arms to record movement. Subjects will perform simple movements during the EEG recording, such as flexing their arm of clenching their fist. Researchers will use the first recording to determine the pattern of how the brain prepares for movement. During the second recording, they will try to predict the subjects' movements, based on the patterns discerned in the first recording.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

HEALTHY VOLUNTEERS:

Healthy volunteers will be over 18, and willing to participate, and able to give informed consent.

STROKE PATIENTS:

The stroke patients will have a clinically and radiologically documented stroke in the sub-acute (2 weeks to 6 months to after onset) or the chronic state (more than 6 months after onset), having a lesion in sub-cortical regions including the basal ganglia, thalamus, internal capsule, or a combination of these structures, or cerebellum unilaterally. These lesions can extend to the surrounding areas, however not including the cortical areas. Patients will be over 18 years of age.

PLS/ALS PATIENTS:

Patients must fulfill the diagnostic criteria proposed by Pringle (1992) for PLS and have been diagnosed with PLS for at least 3 years. Criteria include onset of spasticity alone in adulthood, slow progressive course, no family history, no lower motor neuron signs, and exclusion of known causes of spasticity. ALS patients should have probable or definite ALS by El Escorial criteria. Patients must have evidence of upper and lower motor neuron signs in two or more defined regions: cranial, arms, legs, or torso. Only the PLS/ALS patients who have recently participated in the study under protocol 06-N-0174 will be included. Some subjects will be studied as inpatients.

EXCLUSION CRITERIA:

HEALTHY VOLUNTEERS:

Subjects who are unable to perform simple voluntary movement with both hands.

Subjects who have any neurological or psychiatric conditions.

Subjects who have any implanted metal in or on their bodies that cannot be removed prior to the MRI and MEG scans.

STROKE PATIENTS:

We are investigating a particular EEG pattern associated with voluntary movement that we believe may not be present in patients with multiple strokes that involve the cerebral cortex; therefore, we will exclude this population of stroke patients. We will, however, include patients with multiple strokes if the cerebral cortex was not involved because we hypothesize that the EEG pattern that we are looking for will be preserved in patients with sub-cortical stroke lesions.

A. Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.

B. Patients with multiple stroke lesions that involve the cerebral cortex will be excluded.

C. Subjects with a pre-stroke history of schizophrenia or bipolar disorders will be excluded.

D. Subjects with cancer will be excluded.

E. Patients not capable of giving an informed consent will be excluded.

PLS/ALS PATIENTS:

PLS/ALS patients with a history or evidence of a coexisting or other neurological disorder, such as stroke, epilepsy, Parkinson's disease, polio, ataxia or neuropathy, or a history of traumatic brain injury, skull defects or neurosurgery will be excluded. PLS/ALS patients will have neuropsychological tests of frontal cortex function under protocol 06-N-0174. Patients with scores below 133 (out of 144) on the Mattis dementia rating scale will be classified as impaired patients who are unable to give their own informed consent and will be excluded. PLS/ALS patients who are unable to travel will be excluded. PLS/ALS patients who are respirator dependent will be excluded.

Special Instructions:
Currently Not Provided
Keywords:
Preparation
Subconscious
Recruitment Keyword(s):
Healthy Volunteer
HV
Normal Control
Condition(s):
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Cohen LG, Bandinelli S, Sato S, Kufta C, Hallett M Attenuation in detection of somatosensory stimuli by transcranial magneticstimulation Electroencephalogr Clin Neurophysiol 1991 Oct;81(5):366-76

Guger C, Ramoser H, Pfurtscheller G Real-time EEG analysis with subject-specific spatial patterns for a brain-computer interface (BCI) IEEE Trans Rehabil Eng 2000 Dec;8(4):447-56

Haggard P, Eimer M On the relation between brain potentials and the awareness of voluntary movements Exp Brain Res 1999 May;126(1):128-33

Active Accrual, Protocols Recruiting New Patients

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