600 Participants Needed

Electrical Stimulation for Depression

JC
PC
Overseen ByPatricia Cirillo, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical brain stimulation, known as transcranial direct current stimulation (tDCS), might improve thinking skills in individuals with certain mental health conditions. It includes participants with depression, bipolar disorder, schizophrenia, or a history of traumatic brain injury. Participants will undergo three tDCS sessions to assess potential improvements in brain function. Eligible participants must have a diagnosis based on common mental health guidelines and must not have metal implants or active substance dependence.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of mental health conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are a healthy control, you cannot be on any psychotropic medications (drugs that affect your mind).

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for improving executive function in neuropsychiatric populations?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated for various conditions. For substance use disorders, studies found no negative effects on heart function and no seizures linked to tDCS. In major depressive disorder, tDCS did not increase dropout rates or side effects compared to a placebo.

In ADHD, tDCS is considered safe and may help improve symptoms without serious side effects. For borderline personality disorder, tDCS has a strong safety record, using low current levels that are safe and manageable. Patients with schizophrenia have also tolerated tDCS well, with the most common side effects being mild itching or tingling.

Additionally, in cases of traumatic brain injury, single courses of tDCS have been found safe. For bipolar disorder, active tDCS was reported to be well-tolerated, with any side effects being mild, such as temporary scalp discomfort. Overall, tDCS appears to be a low-risk option for many mental health conditions.12345

Why are researchers excited about this trial?

Researchers are excited about tDCS (transcranial Direct Current Stimulation) because it offers a non-invasive way to potentially alleviate symptoms of depression. Unlike traditional treatments like antidepressants or psychotherapy, tDCS involves a gentle electrical current applied to the scalp, which can modulate brain activity directly. This method could reduce side effects commonly associated with medications and might work faster than traditional therapies. Additionally, the versatility of tDCS in addressing various mental health issues, including major depressive disorder, bipolar disorder, and schizophrenia, holds promise for broad applications.

What evidence suggests that transcranial direct current stimulation (tDCS) is effective for improving executive function in neuropsychiatric populations?

Research shows that transcranial direct current stimulation (tDCS) can help with various mental health issues. In this trial, participants with major depressive disorder will undergo tDCS sessions, as studies indicate that tDCS can greatly reduce symptoms, with more than half of patients experiencing full relief. Participants with substance use disorder will also receive tDCS, which has lowered cravings and reduced relapse rates. For those with ADHD, tDCS helps with inattention and impulsivity, and some studies report lasting benefits. In bipolar disorder, using tDCS along with medication improves depressive symptoms. Early research on borderline personality disorder suggests it aids in managing emotions and impulsivity. Participants with schizophrenia and traumatic brain injury will also join this trial, as tDCS has enhanced thinking skills and recovery. Overall, tDCS appears promising as a non-invasive treatment, with increasing evidence supporting its benefits.12367

Who Is on the Research Team?

JC

Joan Camprodon, MD, PhD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with certain mental health conditions, including traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder, and substance use disorders, based on specific medical criteria.

Exclusion Criteria

Pregnant or nursing females.
Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.
Inability to participate in testing procedures.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three sessions of tDCS: two active sessions and one sham session, with the order randomized

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • tDCS
Trial Overview 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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Traumatic Brain InjuryExperimental Treatment1 Intervention
Group II: Substance Use DisorderExperimental Treatment1 Intervention
Group III: SchizophreniaExperimental Treatment1 Intervention
Group IV: Major Depressive DisorderExperimental Treatment1 Intervention
Group V: Borderline Personality DisorderExperimental Treatment1 Intervention
Group VI: Bipolar DisorderExperimental Treatment1 Intervention
Group VII: Attention Deficit Hyperactivity DisorderExperimental Treatment1 Intervention
Group VIII: Healthy ControlsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34167666/
Transcranial direct current stimulation in attention-deficit/ ...TDCS seems to be a promising method to treat clinical symptoms in ADHD with long-lasting effects. Still, more research considering the individual ...
Prefrontal Transcranial Direct Current Stimulation in ...In this randomized clinical trial involving 69 youths with ADHD, tDCS of the left dorsolateral prefrontal cortex (maximum, 10 sessions) led to significantly ...
Transcranial Direct Current Stimulation in ADHDWith regard to tDCS effects on ADHD clinical symptoms, a large effect size for the inattention subscale was revealed [47, 48] and a medium effect size for ...
Behavioral outcomes after tDCS treatment during ...Our study only showed tDCS-associated impulsivity improvement in children/adolescents with ADHD during follow-ups and anode placement on the ...
Clinical Efficacy and Long Term Effects of Transcranial ...The objective of this project is to evaluate the efficacy of tDCS (vs sham) during cognitive-remediation exercises on ADHD symptoms (inattention, impulsivity ...
Noninvasive Brain Stimulation in Attention-Deficit ...In summary, although tDCS has shown favorable safety and tolerability, definitive evidence for its therapeutic efficacy in improving clinical ...
Efficacy and Safety of Transcranial Direct Current ...The study highlights the potential of tDCS as a viable therapeutic option for ADHD, especially given its ability to improve symptoms without ...
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