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Non-Invasive Electrical Stimulation of the Human Brain

Primary Purpose

Cerebrovascular Disorders, Healthy, Nervous System Diseases

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cerebrovascular Disorders focused on measuring Amputations, Brainstem Stimulation, Cerebellar Stimulation, Cortical Motor Physiology, Electrical Stimulation, Motor Cortex, Plasticity, Spinal Cord Injury, Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Males and females, ages 18 and over. Diverse racial groups. Amputees and others with whom we will have no patient-care relationship may also be considered to be volunteers. Patients will be recruited from those referred to the Human Motor Control Section, NINDS who have neurological syndromes that are of interest. On rare occasions we may attempt to study children as young as 10 years with TES. Individuals without indwelling cardiac lines and pacemakers. Patients recruited for study would come from those referred to the EMG laboratory and to the Human Motor Control Clinic who would have distinct neurologic syndromes from well defined peripheral and central nervous system lesions including hemiplegia from stroke, trauma, tumor or focal demyelination (most commonly patients would have hemiplegia from stroke), peripheral nerve lesions, amputations, spinal cord injury. Normal volunteers, including NIH employees, would be healthy adults without history of physical examination evidence of neurologic disease and individuals with different types of amputations involving upper and lower extremities. Volunteers may also be participants in the electrophysiological protocol (84-N-0196). No history of epilepsy.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001216
Brief Title
Non-Invasive Electrical Stimulation of the Human Brain
Official Title
Non-Invasive Stimulation of the Human Central Nervous System (Digitimer)
Study Type
Observational

2. Study Status

Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
February 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study is designed to allow researchers to use transelectrical stimulation to explore the function of the human nervous system and improve diagnosis of neurological disorders. Transcranial electrical stimulation is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. Electrical stimulation involves placing electrodes on the scalp or skin and passing an electrical current between them. When this is done, an electrical field is created that activates areas of the brain that control muscles. Muscle activity as a result of the stimulation can be recorded and analyzed.
Detailed Description
This protocol application is written to permit us to use transcranial electrical stimulation, a safe and noninvasive method for activating the brain, spinal cord, or proximal nerves through the skin, in appropriate subjects. We will use this technique to explore the function of the human central and peripheral nervous system and to aid in the diagnosis of neurological disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Healthy, Nervous System Diseases, Spinal Cord Injuries
Keywords
Amputations, Brainstem Stimulation, Cerebellar Stimulation, Cortical Motor Physiology, Electrical Stimulation, Motor Cortex, Plasticity, Spinal Cord Injury, Stroke

7. Study Design

Enrollment
175 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Males and females, ages 18 and over. Diverse racial groups. Amputees and others with whom we will have no patient-care relationship may also be considered to be volunteers. Patients will be recruited from those referred to the Human Motor Control Section, NINDS who have neurological syndromes that are of interest. On rare occasions we may attempt to study children as young as 10 years with TES. Individuals without indwelling cardiac lines and pacemakers. Patients recruited for study would come from those referred to the EMG laboratory and to the Human Motor Control Clinic who would have distinct neurologic syndromes from well defined peripheral and central nervous system lesions including hemiplegia from stroke, trauma, tumor or focal demyelination (most commonly patients would have hemiplegia from stroke), peripheral nerve lesions, amputations, spinal cord injury. Normal volunteers, including NIH employees, would be healthy adults without history of physical examination evidence of neurologic disease and individuals with different types of amputations involving upper and lower extremities. Volunteers may also be participants in the electrophysiological protocol (84-N-0196). No history of epilepsy.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2004248
Citation
Cohen LG, Meer J, Tarkka I, Bierner S, Leiderman DB, Dubinsky RM, Sanes JN, Jabbari B, Branscum B, Hallett M. Congenital mirror movements. Abnormal organization of motor pathways in two patients. Brain. 1991 Feb;114 ( Pt 1B):381-403. doi: 10.1093/brain/114.1.381.
Results Reference
background
PubMed Identifier
8467889
Citation
Brasil-Neto JP, Pascual-Leone A, Valls-Sole J, Cammarota A, Cohen LG, Hallett M. Postexercise depression of motor evoked potentials: a measure of central nervous system fatigue. Exp Brain Res. 1993;93(1):181-4. doi: 10.1007/BF00227794.
Results Reference
background
PubMed Identifier
1620338
Citation
Brasil-Neto JP, Cohen LG, Pascual-Leone A, Jabir FK, Wall RT, Hallett M. Rapid reversible modulation of human motor outputs after transient deafferentation of the forearm: a study with transcranial magnetic stimulation. Neurology. 1992 Jul;42(7):1302-6. doi: 10.1212/wnl.42.7.1302.
Results Reference
background

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Non-Invasive Electrical Stimulation of the Human Brain

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