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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01602276
Other study ID # NA_00047863
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date October 10, 2018

Study information

Verified date December 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date October 10, 2018
Est. primary completion date October 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS

Locations

Country Name City State
United States Department of Neurology; Cognitive Neurology/Neuropsychology Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in motor functioning 1 month
Primary Improvement in level of consciousness and alertness 1 month
Primary Improvement in cognitive functioning 1 month
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