Non-Invasive Electrical Stimulation of the Human Brain - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	February 1986
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Non-Invasive Electrical Stimulation of the Human Brain
Official Title ^ICMJE	Non-Invasive Stimulation of the Human Central Nervous System (Digitimer)
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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Cerebrovascular Disorders Healthy Nervous System Diseases Spinal Cord Injuries
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	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. 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. 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.
* 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 ^ICMJE	Completed
Enrollment ^ICMJE	175
Completion Date	February 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001216
Responsible Party
Study ID Numbers ^ICMJE	860020, 86-N-0020
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	December 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP