- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00944931
High-Density Direct Current Brain Polarization
Background:
- Direct current (DC) brain polarization is a technique in which very weak electricity is applied to the head. Doctors have used DC polarization for many years on patients and healthy people with no known serious side effects. Earlier, researchers found that DC polarization can temporarily improve the ability of healthy people to think of certain words.
- A disadvantage of existing methods of DC polarization is that they use large electrodes and the current spreads over a large area of the brain. This makes it difficult to target particular brain areas. High-density DC polarization uses several small electrodes to focus the current in a small area of the brain. This study will test high-density DC polarization for the first time in humans.
Objectives:
- To see how well high-density direct current polarization works in the brain.
- To test a new method of performing direct current brain polarization.
Eligibility:
- Healthy, right-handed adults, ages 18 and older, who have no history of neurological or psychiatric illnesses.
Design:
- After an initial screening visit with clinical examination, participants may be assigned to one or both experiments of the study.
- Experiment 1: Participants will have electrodes placed on the left side of their heads, and will be asked to say aloud as many words as they can think of that begin with certain letters. After the high-density DC polarization current is turned on and run for 10 minutes, participants will say words beginning with a different set of letters and perform reaction time and thinking speed tests. Some participants will receive real polarization and others will not, although all participants will be told that they are receiving the polarization.
- Experiment 2: Participants will have DC brain polarization performed with transcranial magnetic stimulation (TMS), which uses magnetic pulses to activate nerve cells in the brain. We will use TMS to help us understand how far the effect of DC polarization spreads in the brain. After attaching electrodes to a point on the scalp above the ear, researchers will give about 50 TMS pulses to five different places near this area. These pulses will produce some painless muscle twitches in the hand or arm. The TMS pulses will be followed by the DC brain polarization, and then by another set of TMS pulses to see if there are any differences in muscle response.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
The principal objectives are: 1) to explore the effectiveness of anodal high-density direct current (HDDC) stimulation of the brain; and 2) test the focality of the technique.
Study Population:
Up to 81 healthy volunteers over the age of 18 will be enrolled.
Design:
We will perform three studies:
- A parallel trial of anodal and sham HDDC delivered to the lateral prefrontal area,
- An exploratory evaluation of the focality of HDDC in the motor cortex and
- A study to determine whether HDDC can be better targeted using a finite element model (FEM) based on the individual subject's MRI scan (obtained as part of the study).
Outcome Measures:
The primary outcome measures are the effect of anodal HDDC (relative to sham) on category verbal fluency, and the decay in the HDDC-induced change in corticospinal output excitability with distance from the active electrode. Performance on the California Computerized Assessment Package is included as a secondary safety outcome.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Healthy volunteers over age 18
EXCLUSION CRITERIA:
Any history of central nervous system illness or behavioral disorder
Broken skin or other lesions in the area of the electrodes
Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation or potentially worsen the outcome of a burn
Presence of metal in the cranial cavity
Holes in the skull made by trauma or surgery
Pacemakers, medication pumps, and other implanted electronic hardware
Pregnancy (female volunteers who have the potential to become pregnant will have urine pregnancy test performed within 24 hours of participation)
Left handers will be excluded from Experiment 1
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Verbal fluency; focality of effect on MEP (exploratory)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.
- BINDMAN LJ, LIPPOLD OC, REDFEARN JW. Long-lasting changes in the level of the electrical activity of the cerebral cortex produced bypolarizing currents. Nature. 1962 Nov 10;196:584-5. doi: 10.1038/196584a0. No abstract available.
- Bikson M, Radman T, Datta A. Rational modulation of neuronal processing with applied electric fields. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:1616-9. doi: 10.1109/IEMBS.2006.259548.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 090196
- 09-N-0196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteer
-
BiogenRecruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
Angion Biomedica CorpQuotient SciencesNot yet recruitingHealthy VolunteerUnited States
-
University Hospital, ToursRecruitingNeurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults (PROSCEA)Healthy VolunteerFrance
-
BiogenActive, not recruiting
-
TeneoFour Inc.Novotech (Australia) Pty LimitedCompletedHealthy VolunteerAustralia
-
Spero TherapeuticsCompleted
-
AbbVieCompletedHealthy VolunteerUnited States
Clinical Trials on DC Brain Polarization
-
National Institute of Neurological Disorders and...Completed
-
National Institute of Neurological Disorders and...Completed
-
National Institute of Neurological Disorders and...Completed
-
University of Sao PauloCompletedMAjor Depressive DisorderBrazil
-
Douglas Mental Health University InstituteCompletedImpulsive Behavior | Suicidal ImpulsesCanada
-
University of OklahomaVA Office of Research and DevelopmentTerminatedBrain Ischemia | Brain InfarctionUnited States
-
South Warwickshire NHS Foundation TrustAston UniversityUnknownDiabetic Retinopathy | Cataract | Age Related Macular Degeneration | Macular Disease | Pseudophakia | Retinal DiseaseUnited Kingdom
-
National Institute of Mental Health (NIMH)TerminatedMental Disorders | Schizophrenia | Psychosis | Childhood Onset Psychotic DisordersUnited States
-
National Institute of Neurological Disorders and...CompletedPick Disease of the BrainUnited States
-
National Institute of Neurological Disorders and...CompletedDystonia | Focal Hand Dystonia | FHDUnited States