Clinical trial NCT04175041: A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
Official title: A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Transcranial Direct Current Stimulation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Accuracy and Reaction Time in Attention and Working Memory
timeFrame: Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
Secondary outcomes:
measure: Amplitude of Electroencephalogram (EEG) Event Related Potentials
timeFrame: Change Before and After Stimulation on Each of the Four Visits, Average of 2-6 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joan Camprodon, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: