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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04296604
Other study ID # 2014P001428
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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