A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175041
• Other study ID #: 2018P002889
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

Description:

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria (Patients)

1. Male and female outpatients 18-55 years of age

2. A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

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. If on non-stimulant medications, dose must have been stable for at least 4 weeks.

Exclusion Criteria (Patients)

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

2. Active substance dependence (except for tobacco).

3. Pregnant or nursing females.

4. Inability to participate in testing procedures.

Inclusion Criteria (Healthy Control)

1. Male and female outpatients 18-55 years of age

Exclusion Criteria (Healthy Control)

1. Diagnosis of psychiatric of neurological disorder

2. Ongoing treatment with any psychotropic medications.

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

4. Active substance dependence (except for tobacco).

5. Pregnant or nursing females.

6. Inability to participate in testing procedures.

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	Measured using Eriksen Flanker Task (EFT)	Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
Secondary	Amplitude of Electroencephalogram (EEG) Event Related Potentials	Measure of amplitude related to stimulus	Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks