Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of tDCS on Subcortical Brain Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01602276
Recruitment Status : Terminated (Difficulty identifying appropriate patients)
First Posted : May 18, 2012
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE May 18, 2012
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Improvement in motor functioning [ Time Frame: 1 month ]
  • Improvement in level of consciousness and alertness [ Time Frame: 1 month ]
  • Improvement in cognitive functioning [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01602276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of tDCS on Subcortical Brain Functioning
Official Title  ICMJE The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Brain Damage, Chronic
Intervention  ICMJE Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS
Study Arms  ICMJE
  • Experimental: Active Stimulation
    Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
  • Sham Comparator: 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.
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2012)
150
Actual Study Completion Date  ICMJE October 10, 2018
Actual Primary Completion Date October 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602276
Other Study ID Numbers  ICMJE NA_00047863
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry Gordon, M.D., Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP