Clinical trial NCT01602276: The Effect of tDCS on Subcortical Brain Functioning
Official title: The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Damage, Chronic
Keywords: Parkinson's disease
Lewy body dementia
Korsakoff's syndrome
Subcortical Dementia
Huntington's Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in motor functioning
timeFrame: 1 month
measure: Improvement in level of consciousness and alertness
timeFrame: 1 month
measure: Improvement in cognitive functioning
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Department of Neurology; Cognitive Neurology/Neuropsychology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Barry Gordon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: