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The Effect of tDCS on Subcortical Brain Functioning

NCT ID: NCT01602276

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-10-10

Brief Summary

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This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.

Detailed Description

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While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively.

This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current.

Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.

Conditions

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Brain Damage, Chronic

Keywords

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Parkinson's disease Lewy body dementia Korsakoff's syndrome Subcortical Dementia Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Stimulation

Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type PROCEDURE

Anodal, Cathodal or Sham tDCS

Sham Stimulation

Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type PROCEDURE

Anodal, Cathodal or Sham tDCS

Interventions

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Transcranial Direct Current Stimulation (tDCS)

Anodal, Cathodal or Sham tDCS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Fluent in the English language
* History of subcortical brain damage (patient group only)
* No known neurological or cognitive impairment (control group only)

Exclusion Criteria

* Appreciable deficits in hearing
* Schizophrenia, bipolar disorder, or major depression (normal controls only)
* Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only)
* Language-based learning disorder (normal controls only)
* Dementia or Mini-Mental State Exam \<24 for normal control participants
* Any implanted metal device (precludes use of tDCS)
* Any implanted cardiac pacemaker
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barry Gordon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Department of Neurology; Cognitive Neurology/Neuropsychology

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00047863

Identifier Type: -

Identifier Source: org_study_id