NCT00029939

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2002

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2002

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2010

Completed
Last Updated

July 2, 2017

Status Verified

November 23, 2010

First QC Date

January 26, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

PreparationSubconsciousHealthy VolunteerHVNormal Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Cohen LG, Bandinelli S, Sato S, Kufta C, Hallett M. Attenuation in detection of somatosensory stimuli by transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):366-76. doi: 10.1016/0168-5597(91)90026-t.

    PMID: 1718723BACKGROUND
  • 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. doi: 10.1109/86.895947.

    PMID: 11204035BACKGROUND
  • 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. doi: 10.1007/s002210050722.

    PMID: 10333013BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 26, 2002

First Posted

January 28, 2002

Study Start

January 22, 2002

Study Completion

November 23, 2010

Last Updated

July 2, 2017

Record last verified: 2010-11-23

Locations