The Effect of tDCS on Subcortical Brain Functioning

Not Applicable

Terminated

• Conditions: Brain Damage, Chronic
• Interventions: Procedure: Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT01602276
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2018-10-09
• Study Completion: 2018-10-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Transcranial Direct Current Stimulation (tDCS)	Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.
Active Stimulation	Transcranial Direct Current Stimulation (tDCS)	Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest

Primary Outcome Measures

Name	Time	Method
Improvement in motor functioning	1 month
Improvement in level of consciousness and alertness	1 month
Improvement in cognitive functioning	1 month

Trial Locations

Locations (1)

Department of Neurology; Cognitive Neurology/Neuropsychology; 🇺🇸 Baltimore, Maryland, United States