The Effect of tDCS on Subcortical Brain Functioning
Primary Purpose
Brain Damage, Chronic
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Brain Damage, Chronic focused on measuring Parkinson's disease, Lewy body dementia, Korsakoff's syndrome, Subcortical Dementia, Huntington's Disease
Eligibility Criteria
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
Sites / Locations
- Department of Neurology; Cognitive Neurology/Neuropsychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Stimulation
Sham Stimulation
Arm Description
Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest
Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.
Outcomes
Primary Outcome Measures
Improvement in motor functioning
Improvement in level of consciousness and alertness
Improvement in cognitive functioning
Secondary Outcome Measures
Full Information
NCT ID
NCT01602276
First Posted
May 14, 2012
Last Updated
December 18, 2018
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01602276
Brief Title
The Effect of tDCS on Subcortical Brain Functioning
Official Title
The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty identifying appropriate patients
Study Start Date
February 2012 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Damage, Chronic
Keywords
Parkinson's disease, Lewy body dementia, Korsakoff's syndrome, Subcortical Dementia, Huntington's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Stimulation
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.
Intervention Type
Procedure
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Anodal, Cathodal or Sham tDCS
Primary Outcome Measure Information:
Title
Improvement in motor functioning
Time Frame
1 month
Title
Improvement in level of consciousness and alertness
Time Frame
1 month
Title
Improvement in cognitive functioning
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Gordon, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology; Cognitive Neurology/Neuropsychology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
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The Effect of tDCS on Subcortical Brain Functioning
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