Clinical trial NCT04296604: Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Official title: Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Attention Deficit Hyperactivity Disorder
Borderline Personality Disorder
Substance Use Disorders
Keywords: Transcranial Direct Current Stimulation
Executive Function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Male and female outpatients 18-65 years of age
2. 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

1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.
2. Active substance dependence (except for tobacco and cannabis).
3. Pregnant or nursing females.
4. Inability to participate in testing procedures.
5. Additional exclusion criteria for healthy controls:

   1. Diagnosis of psychiatric of neurological disorder
   2. Ongoing treatment with any psychotropic medications.

Primary outcomes:
measure: Change in N-Back Task
timeFrame: Baseline to Post-Treatment, 1 Week
Secondary outcomes:
measure: Change in Flanker Task
timeFrame: Baseline to Post-Treatment, 1 Week
measure: Change in Multi-Source Interference with International Affective Picture System Task
timeFrame: Baseline to Post-Treatment, 1 Week
measure: Change in Delayed Discounting Task
timeFrame: Baseline to Post-Treatment, 1 Week
measure: Change in Stop Signal Task
timeFrame: Baseline to Post-Treatment, 1 Week
measure: Change in Iowa Gambling Task
timeFrame: Baseline to Post-Treatment, 1 Week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joan Camprodon, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: