The Effect of tDCS on Subcortical Brain Functioning

NCT01602276 | Terminated DMC

• 1 other identifier: NA_00047863
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Damage, Chronic

Keywords

Parkinson's disease; Lewy body dementia; Korsakoff's syndrome; Subcortical Dementia; Huntington's Disease

Outcome Measures

Primary Outcomes (3)

• Improvement in motor functioning

  1 month

• Improvement in level of consciousness and alertness

  1 month

• Improvement in cognitive functioning

  1 month

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest

Procedure: Transcranial Direct Current Stimulation (tDCS)

Sham Stimulation

SHAM COMPARATOR

Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) PROCEDURE

Anodal, Cathodal or Sham tDCS

Active Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in the English language
• History of subcortical brain damage (patient group only)
• No known neurological or cognitive impairment (control group only)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Department of Neurology; Cognitive Neurology/Neuropsychology

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Brain Damage, Chronic; Parkinson Disease; Lewy Body Disease; Korsakoff Syndrome; Huntington Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Barry Gordon, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 18, 2012
• Study Start: February 1, 2012
• Primary Completion: October 9, 2018
• Study Completion: October 10, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

US (1)