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Neuromodulation
Brain Zapping for ADHD
N/A
Recruiting
Led By Joan Camprodon, MD, PhD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female subjects 18-66 years of age
Be older than 18 years old
Must not have
Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders
Ongoing treatment with any psychotropic medications for healthy controls
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change before and after stimulation on each of the three visits, average 2-6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will use brain zapping to study the effects of tDCS on executive function and inhibitory control in patients with ADHD compared to healthy controls.
Who is the study for?
This trial is for English-speaking adults aged 18-66 with ADHD, diagnosed per DSM-5 criteria. Participants can be on stimulants but must stop them two days before each study visit. Excluded are those with unstable psychiatric conditions, metal implants in the head/neck, brain stimulators, or who are pregnant/nursing.
What is being tested?
The study tests how transcranial direct current stimulation (tDCS) affects executive function and self-control in adults with ADHD compared to healthy individuals. It examines the temporary changes caused by this non-invasive brain stimulation technique.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching or tingling during stimulation, headache, fatigue, nausea or dizziness. Serious risks like seizures are rare but possible in susceptible individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 66 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a history of severe mental health issues like suicidal thoughts or psychosis.
Select...
I am currently taking medication for mental health.
Select...
I do not have any psychiatric or neurological disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change before and after stimulation on each of the three visits, average 2-6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change before and after stimulation on each of the three visits, average 2-6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Accuracy and Reaction Time in Attention and Working Memory
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Secondary study objectives
Amplitude of Encephalogram (EEG) Event Related Potentials
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Healthy ControlExperimental Treatment1 Intervention
Volunteers without Neuropsychiatric Disorders.
Group II: ADHDExperimental Treatment1 Intervention
Patients with ADHD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,829 Total Patients Enrolled
59 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
8,397 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Joan Camprodon, MD, PhD, MPHPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
864 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
704 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 66 years old.I do not have a history of severe mental health issues like suicidal thoughts or psychosis.I am currently taking medication for mental health.I will stop taking stimulant medications two days before the experiment, as advised by my doctor.I do not have any psychiatric or neurological disorders.I am healthy or was diagnosed with ADHD as an adult.I can follow the taper plan if I experience fatigue from stopping medication.I can stop my stimulant medication for 2 days before each study visit.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Control
- Group 2: ADHD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04175028 — N/A