What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) and similar neuromodulation treatments like Transcranial Magnetic Stimulation (TMS) and Deep Brain Stimulation (DBS) are generally well-tolerated but can have side effects. Common side effects of tDCS and TMS include mild headaches, scalp discomfort, tingling, and lightheadedness. More severe but rare side effects can include seizures. Deep Brain Stimulation (DBS) is more invasive and can cause complications such as infection, hemorrhage, confusion, and seizures, although these are uncommon. Hardware malfunctions are more frequent but usually correctable. Overall, while these treatments can be effective, they come with a range of potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for mental health disorders, including repetitive Transcranial Magnetic Stimulation (rTMS) and Vagus Nerve Stimulation (VNS). rTMS, which modulates neuronal activity through magnetic fields, is approved for treatment-resistant depression. VNS, which involves electrical stimulation of the vagus nerve, is approved for treatment-resistant depression and epilepsy. While tDCS, which uses direct electrical currents to modulate brain activity, is still under investigation, these approved treatments share the common goal of altering brain activity to alleviate symptoms of mental health disorders.

What other types of research exist?

Promising, novel alternatives to Transcranial Direct Current Stimulation (tDCS) for mental health disorders in 2024 include: 1) Neurofeedback, which has shown neurocognitive benefits in ADHD and other conditions. 2) Transcranial Magnetic Stimulation (TMS), particularly repetitive TMS (rTMS), which has demonstrated efficacy in treating depression and other disorders. 3) Deep Brain Stimulation (DBS), which is being explored for treatment-resistant conditions like OCD and depression. These alternatives offer different mechanisms of action and have shown potential in clinical trials.

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Noninvasive Brain Stimulation

Transcranial Direct Current Stimulation for Pediatric OCD

N/A

Recruiting

Led By Daniel Geller, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Outpatient youth between the ages 10-17 years

Be younger than 18 years old

Must not have

Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.

Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session

Awards & highlights

Summary

This trial is testing tDCS, a method using a small electrical current on the scalp, in children with OCD. The goal is to see if it can help normalize their brain function and improve symptoms. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been extensively investigated in adults with psychiatric disorders, including depression and anxiety.

Who is the study for?

This trial is for kids aged 10-17 with moderate to severe OCD, as measured by a specific scale. They must have an IQ of at least 85 and speak English. Kids can't join if they've had recent medication changes, certain mental health diagnoses, are underweight, pregnant or nursing, or have metal implants in the head/neck.

What is being tested?

The study tests how transcranial direct current stimulation (tDCS) affects brain processes related to OCD in children. It's non-invasive and aims to modulate neural activity that contributes to the disorder.

What are the potential side effects?

While tDCS is generally considered safe, potential side effects may include mild itching, tingling or discomfort at the electrode sites during stimulation. There could also be fatigue or headache after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had suicidal thoughts or behaviors in the last 6 months.

Select...

I don't have epilepsy, metal implants in my head/neck, brain devices, or a pacemaker.

Select...

I do not have a severe illness that could hospitalize me during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fear Extinction Recall Task

Change in Sequential Spaceship Task

Change in Stop Signal Task

Secondary study objectives

Change in EEG readings

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

skin irritation

Car accident

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Inhibitory Control/ Goal-Orientated vs Habit-Based BehaviorExperimental Treatment1 Intervention

This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Group II: Inhibitory Control/ Fear ExtinctionExperimental Treatment1 Intervention

This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. 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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Direct Current Stimulation (tDCS) and similar neuromodulation treatments, such as repetitive Transcranial Magnetic Stimulation (rTMS) and Electroconvulsive Therapy (ECT), work by modulating neuronal activity and connectivity in the brain. tDCS uses low electrical currents to stimulate specific brain regions, potentially enhancing or inhibiting neuronal activity to improve symptoms. rTMS uses magnetic fields to induce electrical currents in the brain, targeting areas involved in mood regulation. ECT involves brief electrical stimulation to induce controlled seizures, which can reset abnormal brain activity patterns. These treatments are important for mental health disorder patients as they offer alternative options when traditional pharmacotherapy is ineffective, providing potential relief from symptoms by directly influencing brain function.