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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296604
• Other study ID #: 2014P001428
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Joan Camprodon, MD, PhD, MPH
• Phone: 6177265348
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Bipolar Disorder
• Borderline Personality Disorder
• Brain Injuries
• Brain Injuries, Traumatic
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Personality Disorders
• Schizophrenia
• Substance Use Disorders
• Substance-Related Disorders
• Traumatic Brain Injury

Intervention

Device:
• Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in N-Back Task	Working Memory Task	Baseline to Post-Treatment, 1 Week
Secondary	Change in Flanker Task	Attention and Inhibitory Control Task	Baseline to Post-Treatment, 1 Week
Secondary	Change in Multi-Source Interference with International Affective Picture System Task	Cognitive Control During Emotional Regulation Task	Baseline to Post-Treatment, 1 Week
Secondary	Change in Delayed Discounting Task	Decision-Making Task	Baseline to Post-Treatment, 1 Week
Secondary	Change in Stop Signal Task	Ability to Inhibit a Response Task	Baseline to Post-Treatment, 1 Week
Secondary	Change in Iowa Gambling Task	Risk-Taking Task	Baseline to Post-Treatment, 1 Week