tDCS for Bipolar Disorder

Overseen By Alexandre P Diaz, MD,PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Drugs (except alcohol, nicotine)

Disqualifiers: Substance abuse, Personality disorder, Neurological conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether a gentle electrical stimulation of the brain can help people who struggle to feel pleasure. The treatment targets specific brain pathways involved in reward and pleasure. Researchers want to see if this method can improve symptoms by activating these pathways.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used drugs (except alcohol or nicotine) in the month before starting the study.

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

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious adverse effects reported in over 33,200 sessions across various populations, including potentially vulnerable groups. Mild side effects like headaches and skin sensations are possible, but serious injuries are unlikely at the typical doses used in studies. ^{1 2 3 4 5}

How is tDCS treatment different from other treatments for bipolar disorder?

tDCS (transcranial direct current stimulation) is a unique treatment for bipolar disorder because it is a non-invasive technique that uses a mild electrical current to stimulate specific brain areas, potentially improving mood and cognitive functions. Unlike medications, it has fewer severe side effects and can be used as an add-on therapy to enhance the effects of other treatments. ^{3 5 6 7 8}

What data supports the effectiveness of the treatment tDCS for Bipolar Disorder?

Preliminary data suggests that tDCS may help improve depressive symptoms in bipolar disorder and enhance cognitive functions like memory and attention in stable patients. However, more large-scale studies are needed to confirm its effectiveness. ^{3 5 6 7 8}

Who Is on the Research Team?

Jair C Soares, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with Bipolar Disorder who experience significant anhedonia (loss of pleasure) and mild depression symptoms. It's not suitable for those with recent substance abuse, personality disorders that affect participation, previous neurological conditions, severe medical issues, metal in the head, or if they're acutely suicidal or severely agitated.

Inclusion Criteria

I experience mild feelings of sadness or hopelessness.

I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.

I experience mild depression symptoms.

Exclusion Criteria

You have a personality disorder that may make it difficult for you to take part in the study.

You have metal plates in your head that can't be used with the treatment.

You have a history of using drugs or being dependent on them, except for alcohol or nicotine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct-current stimulation (tDCS) or sham tDCS to engage reward-related brain circuitry

6 weeks

Weekly visits for tDCS sessions

Follow-up

Participants are monitored for changes in symptoms of anhedonia and brain imaging outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique. Participants will receive either active tDCS or a sham (placebo) treatment to see if it affects brain circuits related to reward and improves feelings of pleasure.

How Is the Trial Designed?

Group I: active tDCS Experimental Treatment 1 Intervention

Group II: sham tDCS Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Milken Institute

Collaborator

Trials

8

Recruited

270+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) applied to the prefrontal and cerebellar regions significantly improved neuropsychological functioning in 25 euthymic patients with bipolar disorder over a 3-week period.

Patients demonstrated notable enhancements in visuospatial memory and executive functioning, particularly those with initially poorer cognitive performance, suggesting that tDCS may effectively modulate disrupted brain circuits in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefronto-cerebellar transcranial direct current stimulation improves visuospatial memory, executive functions, and neurological soft signs in patients with euthymic bipolar disorder. Minichino, A., Bersani, FS., Bernabei, L., et al.[2020]

Transcranial Direct Current Stimulation (tDCS) shows promise in improving depressive symptoms in patients with bipolar disorder, based on data from 10 studies involving 170 patients.

While tDCS is generally safe with mostly mild side effects, there have been rare reports of hypomanic or manic episodes, indicating the need for more controlled trials to better understand its efficacy and safety in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Transcranial Direct Current Stimulation (tDCS) on Bipolar Depression, Mania, and Euthymia: a Systematic Review of Preliminary Data. Dondé, C., Neufeld, NH., Geoffroy, PA.[2019]

Transcranial direct current stimulation (tDCS) is a non-invasive treatment that has been used for bipolar depression, but there is a risk of triggering mania or hypomania in some patients.

A case study of a female patient with bipolar II depression showed that she quickly developed hypomanic symptoms during bifrontal tDCS, highlighting the need for caution when using this treatment in bipolar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypomania Induced by Bifrontal Transcranial Direct Current Stimulation in a Patient with Bipolar Depression. Chao, PC., Chang, CC., Chang, HA.[2020]

Transcranial direct current stimulation (tDCS) was found to be an effective add-on treatment for bipolar depression, showing significant improvement in depression scores compared to a sham treatment in a trial involving 59 adults.

The treatment was generally safe and well-tolerated, with similar adverse events between the active and sham groups, although localized skin redness was more common in the tDCS group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial. Sampaio-Junior, B., Tortella, G., Borrione, L., et al.[2019]

In a study involving 15 euthymic patients with bipolar disorder, transcranial direct current stimulation (tDCS) did not significantly enhance working memory or sustained attention, with only about one-third showing any improvement in working memory.

The results suggest that a single session of tDCS, whether targeting the prefrontal or fronto-cerebellar areas, is not effective for cognitive enhancement in this patient group, indicating the need for further research on tDCS applications in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to enhance cognition in euthymic bipolar disorder. Martin, DM., Chan, HN., Alonzo, A., et al.[2018]

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]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Prefronto-cerebellar transcranial direct current stimulation improves visuospatial memory, executive functions, and neurological soft signs in patients with euthymic bipolar disorder. [2020]

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

The Impact of Transcranial Direct Current Stimulation (tDCS) on Bipolar Depression, Mania, and Euthymia: a Systematic Review of Preliminary Data. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypomania Induced by Bifrontal Transcranial Direct Current Stimulation in a Patient with Bipolar Depression. [2020]

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

Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to enhance cognition in euthymic bipolar disorder. [2018]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]