Transcranial Direct Current Stimulation for Pediatric OCD

Overseen By Saffron Homayoun, MBChB

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Suicidality, Conduct disorder, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial requires that your current medications remain stable during the study. If you are on psychotropic medications, they must not have changed within 8 weeks before the study (6 weeks for antipsychotics). You cannot start new antidepressants within 12 weeks or new antipsychotics within 6 weeks before the study. Any changes due to side effects will be discussed with the study psychiatrist.

Will I have to stop taking my current medications?

The trial requires that any current medications must remain stable during the study. If you are on psychotropic medications, they should not have changed within 8 weeks before joining the study (6 weeks for antipsychotics).

What data supports the idea that Transcranial Direct Current Stimulation for Pediatric OCD is an effective treatment?

The available research shows that Transcranial Direct Current Stimulation (tDCS) may help reduce symptoms in patients with treatment-resistant OCD. Although the studies are limited and vary in how they apply the treatment, some patients have experienced improvements in OCD symptoms, as well as in related issues like depression and anxiety. However, more research is needed to confirm these findings, as there are no studies that compare tDCS to a placebo treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for Pediatric OCD?

Research suggests that tDCS, a treatment using a mild electrical current to influence brain activity, may help reduce symptoms of OCD, depression, and anxiety in patients who haven't responded to other treatments. However, more studies are needed to confirm these findings, as current evidence is limited and lacks rigorous control. ^{1 2 3 4 5}

What safety data exists for tDCS in children?

Existing safety data for transcranial direct current stimulation (tDCS) in children is limited but suggests it is generally safe and tolerable. Studies report minor side effects such as tingling, itching, mood changes, and irritability. Systematic reviews indicate that adverse events are low and transient, but more research is needed to confirm long-term safety, especially considering the developing brain. ^{6 7 8 9 10}

Is transcranial direct current stimulation (tDCS) safe for children?

Transcranial direct current stimulation (tDCS) is generally considered safe and well-tolerated in children, with common side effects being mild, such as tingling, itching, mood changes, and irritability. However, more research is needed to fully understand its long-term safety in young people. ^{6 7 8 9 10}

Is Transcranial Direct Current Stimulation (tDCS) a promising treatment for Pediatric OCD?

Transcranial Direct Current Stimulation (tDCS) is a promising treatment for Pediatric OCD because it is a non-invasive method that can help reduce symptoms and improve cognitive function in children and adolescents. It is well-tolerated, meaning most kids can handle it without problems, and early studies show it might be safe and effective for young people with psychiatric disorders. ^{10 11 12 13 14}

How is transcranial direct current stimulation (tDCS) different from other treatments for pediatric OCD?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive treatment that uses a weak electric current applied to the scalp to modulate brain activity, unlike traditional medications or therapies. It is still being researched for its effects on the developing brain, but early studies suggest it is safe and well-tolerated in children and adolescents. ^{10 11 12 13 14}

Research Team

Joan Camprodon, MD, MPH, PhD

Principal Investigator

Massachusetts General Hospital

Daniel Geller, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am between 10 and 17 years old.

English speaking.

Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) ≥16 (moderately severe). OCD must be determined to be the primary or co-primary diagnosis using the The Schedule for Affective Disorders and Schizophrenia for School-Age Children- Computer administered version (KSADS-COMP) based on all available information.

Exclusion Criteria

I am a young person with symptoms of hoarding.

You have been diagnosed with certain mental health conditions like conduct disorder, autism, bipolar disorder, ADHD, Tourette's syndrome, schizophrenia, or schizoaffective disorders based on DSM-V criteria.

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

Timeline

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

3 sessions (in-person)

Follow-up

Participants are monitored for changes in neurocognitive processes after tDCS sessions.

1-2 weeks

Treatment Details

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview 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.

Participant Groups

Group I: Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior Experimental Treatment 1 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 Extinction Experimental Treatment 1 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.

Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Transcranial direct current stimulation (tDCS) shows promise in improving symptoms of treatment-resistant obsessive-compulsive disorder (OCD), with 78 patients reporting symptom relief, particularly in OCD, depression, and anxiety.

Current evidence is limited due to the absence of sham-controlled studies and the variability in stimulation parameters, highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation (tDCS) for obsessive-compulsive disorder: A new treatment option?] Palm, U., Brunelin, J., Wulf, L., et al.[2020]

In a study of 32 patients with treatment-resistant obsessive-compulsive disorder (OCD), 28% showed at least a partial response to transcranial direct current stimulation (tDCS) after 10-20 sessions.

Among the responders, 25% had a significant improvement, suggesting that tDCS could be a beneficial treatment option for some individuals who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder-A large case series. Thamby, A., Seshachala, K., Sharma, L., et al.[2021]

In a study involving 24 OCD patients, 10 sessions of high-definition transcranial direct current stimulation (tDCS) significantly reduced OCD symptoms, as measured by the Yale-Brown Obsessive-Compulsive Scale, along with improvements in depression and anxiety scores.

The treatment also led to a notable decrease in TMS-evoked N100 amplitude, suggesting a modulation of GABAB receptor function, which was initially higher in OCD patients compared to healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improve symptoms and modulates cortical inhibition in obsessive-compulsive disorder: A TMS-EEG study. Cheng, J., Li, P., Tang, Y., et al.[2022]

Transcranial direct current stimulation (tDCS) shows promise as a treatment for patients with treatment-resistant obsessive-compulsive disorder (OCD), with 77 patients in various studies reporting decreased symptoms, including comorbid depression and anxiety.

Current research lacks sham-controlled studies, highlighting the need for more rigorous trials to confirm the efficacy of tDCS and to standardize treatment parameters, as existing studies have methodological limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: A Systematic Review. Brunelin, J., Mondino, M., Bation, R., et al.[2020]

In a clinical trial involving 21 treatment-resistant OCD patients, cathodal transcranial direct current stimulation (tDCS) over the supplementary motor area showed a significant reduction in obsessive-compulsive symptoms after one month, with 24% of patients meeting the criteria for treatment response.

The treatment was well tolerated, with only mild side effects like tingling and skin redness reported, indicating that tDCS could be a safe and promising option for patients who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. Harika-Germaneau, G., Heit, D., Chatard, A., et al.[2021]

Transcranial direct current stimulation (tDCS) appears to be safe and well-tolerated in youth, based on a synthesis of studies involving 156 children and a total of 864 active sessions.

The reviewed literature supports the acceptability of tDCS in pediatric populations, with only a small percentage of sessions (4.4%) conducted on neurotypical controls, indicating a focus on clinical subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Buchanan, DM., Bogdanowicz, T., Khanna, N., et al.[2021]

Transcranial direct current stimulation (tDCS) is a feasible and tolerable treatment for children aged 5 to 12 with language disorders, based on a study involving 14 children who received 10 sessions.

While tDCS had minimal side effects, the most common were tingling and itching (28.6%), along with acute mood changes (42.9%) and irritability (35.7%), indicating that while generally safe, monitoring for these effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transcranial direct current stimulation use in children aged 5 to 12 years. Andrade, AC., Magnavita, GM., Allegro, JV., et al.[2014]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) has been found to be safe and well-tolerated in children and adolescents with neurodevelopmental disorders, such as ADHD and autism, based on early short-term studies.

Preliminary evidence suggests that tDCS may help reduce symptoms and improve cognitive function in these youth, but more extensive research is needed to understand its effects on the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatric Disorders. Lee, JC., Kenney-Jung, DL., Blacker, CJ., et al.[2019]

Transcranial direct current stimulation (tDCS) appears to be well tolerated and safe for children and adolescents with various psychiatric disorders, based on a review of six studies, including three randomized clinical trials.

However, due to the limited number of studies and the need for more rigorous research, definitive conclusions about its efficacy compared to standard treatments cannot yet be made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. Muszkat, D., Polanczyk, GV., Dias, TG., et al.[2018]

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

A case study involving a 10-year-old with perinatal stroke established that a tDCS dose of 0.7 mA for 10 minutes is optimal for children, providing similar brain current intensity to adults receiving 1.0 mA, while ensuring safety and tolerability.

The study utilized advanced computational modeling to customize tDCS parameters, suggesting that tailored dosing approaches can enhance the safety and efficacy of tDCS in pediatric applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. Gillick, BT., Kirton, A., Carmel, JB., et al.[2021]

Transcranial direct current stimulation (tDCS) at 1mA for 10 minutes is well tolerated in children and adolescents aged 11-16, with a low rate of adverse events and no serious complications reported.

The study found no signs of harmful effects, such as epileptiform activity, in EEG recordings, suggesting that tDCS is a safe method for modulating brain activity in the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. Moliadze, V., Andreas, S., Lyzhko, E., et al.[2015]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation (tDCS) for obsessive-compulsive disorder: A new treatment option?] [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder-A large case series. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improve symptoms and modulates cortical inhibition in obsessive-compulsive disorder: A TMS-EEG study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: A Systematic Review. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of transcranial direct current stimulation use in children aged 5 to 12 years. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatric Disorders. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Ten minutes of 1 mA transcranial direct current stimulation was well tolerated by children and adolescents: Self-reports and resting state EEG analysis. [2015]