Clinical trial NCT04175028: Neuromodulation of Executive Function in the ADHD Brain
Official title: Neuromodulation of Executive Function in the ADHD Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Executive Function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Accuracy and Reaction Time in Attention and Working Memory
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
measure: Change in Accuracy and Reaction Time in Attention and Working Memory
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
measure: Change in Accuracy and Reaction Time in Attention and Working Memory
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
measure: Change in Accuracy and Reaction Time in Inhibition/Decision Making
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
measure: Change in Accuracy and Reaction Time in Inhibition/Decision Making
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
measure: Change in Accuracy and Reaction Time in Inhibition/Decision Making
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Secondary outcomes:
measure: Amplitude of Encephalogram (EEG) Event Related Potentials
timeFrame: Change Before and After Stimulation on Each of the Three Visits, Average 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:
citation: Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.