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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ADHD

Patients with ADHD.

Group Type OTHER

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Healthy Control

Volunteers without Neuropsychiatric Disorders.

Group Type OTHER

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Interventions

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Transcranial Direct Current Stimulation

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

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

Exclusion Criteria

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes