Neuromodulation of Executive Function in the ADHD Brain

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Neuromodulation of Executive Function in the ADHD Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04175028
• Other study ID #: 2014P001401
• 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: 61772656348
• Email: jcamprodon[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.

Description:

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD. Deficits in these cognitive functions are core to ADHD, and cause significant impairment and morbidity. The study will also include a cohort of healthy controls for comparison.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria

1. Male and female subjects 18-66 years of age

2. Healthy volunteers or volunteers with a diagnosis of ADHD in adulthood, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [American Psychiatric Association, 2013] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.

3. Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).

4. English-speaking Exclusion Criteria

1. Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.

2. Pregnant or nursing females.

3. Inability to participate in testing procedures

4. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.

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

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 Accuracy and Reaction Time in Attention and Working Memory	N-Back Task	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Primary	Change in Accuracy and Reaction Time in Attention and Working Memory	Flanker Task	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Primary	Change in Accuracy and Reaction Time in Attention and Working Memory	Multi-Source Interference with International Affective Picture System Task	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Primary	Change in Accuracy and Reaction Time in Inhibition/Decision Making	Delayed Discounting	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Primary	Change in Accuracy and Reaction Time in Inhibition/Decision Making	Stop Signal Task	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Primary	Change in Accuracy and Reaction Time in Inhibition/Decision Making	Cambridge Gambling Task	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Secondary	Amplitude of Encephalogram (EEG) Event Related Potentials	Measure of amplitude related to stimulus	Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks