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Neuromodulation Device

Electrical Stimulation for Depression

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-treatment, 1 week
Awards & highlights

Summary

This trial will test if electrical stimulation can help improve executive function in people with neuropsychiatric conditions.

Who is the study for?
This trial is for adults aged 18-65 with certain neuropsychiatric conditions like traumatic brain injury, major depression, bipolar disorder, schizophrenia, ADHD, borderline personality disorder, and substance use disorders. It's not for pregnant or nursing women or those with epilepsy, metal implants in the head/neck area, brain stimulators or pacemakers.Check my eligibility
What is being tested?
The study is testing whether transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, can improve executive functions such as decision-making and self-control in people with various neuropsychiatric disorders.See study design
What are the potential side effects?
tDCS is generally considered safe but may cause mild side effects like itching or tingling at the electrode site on the scalp during application. There might also be temporary headaches or fatigue after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-treatment, 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-treatment, 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in N-Back Task
Secondary outcome measures
Change in Delayed Discounting Task
Change in Flanker Task
Change in Iowa Gambling Task
+2 more

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468
2%
Car accident
2%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Traumatic Brain InjuryExperimental Treatment1 Intervention
This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group II: Substance Use DisorderExperimental Treatment1 Intervention
This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group III: SchizophreniaExperimental Treatment1 Intervention
This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group IV: Major Depressive DisorderExperimental Treatment1 Intervention
This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group V: Borderline Personality DisorderExperimental Treatment1 Intervention
This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group VI: Bipolar DisorderExperimental Treatment1 Intervention
This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group VII: Attention Deficit Hyperactivity DisorderExperimental Treatment1 Intervention
This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Group VIII: Healthy ControlsActive Control1 Intervention
This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
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
2,955 Previous Clinical Trials
13,212,078 Total Patients Enrolled
Joan Camprodon, MD, PhD, MPHPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
384 Total Patients Enrolled
~5 spots leftby Sep 2024