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Clinical Trials/NCT04296604
NCT04296604RecruitingNot Applicable

Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations

Massachusetts General Hospital1 site in 1 country600 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
600
Locations
1
Primary Endpoint
Change in N-Back Task

Study Overview

Brief Summary

In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.

Detailed Description

In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. The investigators will select 8 relevant diagnostic categories: traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorder. The study will also include a cohort of healthy controls for comparison.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male and female outpatients 18-65 years of age
  • •A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria

  • •Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.
  • •Active substance dependence (except for tobacco and cannabis).
  • •Pregnant or nursing females.
  • •Inability to participate in testing procedures.
  • •Additional exclusion criteria for healthy controls:
  • •Diagnosis of psychiatric of neurological disorder
  • •Ongoing treatment with any psychotropic medications.

Arms & Interventions

Traumatic Brain Injury

Experimental

This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Major Depressive Disorder

Experimental

This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Bipolar Disorder

Experimental

This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Schizophrenia

Experimental

This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Attention Deficit Hyperactivity Disorder

Experimental

This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Borderline Personality Disorder

Experimental

This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Substance Use Disorder

Experimental

This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Healthy Controls

Active Comparator

This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Intervention: Transcranial Direct Current Stimulation (Device)

Outcomes

Primary Outcomes

Change in N-Back Task

Time Frame: Baseline to Post-Treatment, 1 Week

Working Memory Task

Secondary Outcomes

  • Change in Multi-Source Interference with International Affective Picture System Task(Baseline to Post-Treatment, 1 Week)
  • Change in Stop Signal Task(Baseline to Post-Treatment, 1 Week)
  • Change in Iowa Gambling Task(Baseline to Post-Treatment, 1 Week)
  • Change in Delayed Discounting Task(Baseline to Post-Treatment, 1 Week)
  • Change in Flanker Task(Baseline to Post-Treatment, 1 Week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Massachusetts General Hospital

Study Sites (1)

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