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 tests a treatment called transcranial direct-current stimulation (tDCS) to determine its effectiveness for people with bipolar disorder who experience anhedonia (a lack of interest or pleasure in activities). Researchers aim to discover if tDCS can alter communication between certain brain areas and affect feelings of pleasure. The study includes two groups: one receiving active tDCS and another receiving a sham (inactive) version for comparison. Ideal participants are those with bipolar disorder who often feel little joy and have mild depression. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mental health treatments.

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.

What prior data suggests that transcranial direct-current stimulation (tDCS) is safe for treating bipolar disorder?

Research has shown that transcranial direct-current stimulation (tDCS) is generally safe and well-tolerated, with studies finding it causes few side effects. For example, one study reported only mild issues, such as brief scalp discomfort. Another study found that tDCS was safe and acceptable for home use in people with bipolar depression. While one study noted a slightly higher risk of temporary mood changes in people with unipolar depression, these changes were not serious. Overall, based on current research, tDCS appears to be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tDCS, or transcranial direct current stimulation, for bipolar disorder because it offers a non-invasive approach to treatment. Unlike traditional medications that alter brain chemistry and often come with side effects, tDCS uses a mild electrical current to modulate brain activity directly. This method could lead to fewer side effects and a different way to manage mood stabilization. Additionally, because tDCS is administered externally, it provides a novel delivery method compared to oral or injectable medications. This innovation has the potential to change the landscape of therapy for individuals with bipolar disorder.

What evidence suggests that tDCS might be an effective treatment for bipolar disorder?

This trial will compare active transcranial direct current stimulation (tDCS) with sham tDCS for treating bipolar disorder. Studies have shown that tDCS can reduce symptoms of depression in bipolar disorder. Research indicates that using tDCS alongside regular medications can improve overall symptoms. In cases of bipolar depression, tDCS has been linked to enhanced cognitive skills, such as improved word learning. It is also considered a safe and affordable treatment with few side effects. Initial findings suggest that tDCS might help by activating specific brain areas related to mood and motivation. ^{1 6 7 8 9}

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

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]

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]

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]

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) 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666915324001045

Evaluating the effectiveness of transcranial direct current ... The present study indicated that tDCS might be an efficient and safe method for improving cognitive function in euthymic bipolar patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39162912/

Home-based transcranial direct current stimulation in bipolar ... Home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability in bipolar depression.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5838572/

Efficacy and Safety of Transcranial Direct Current ... Transcranial direct current stimulation is an affordable therapy with few adverse events that showed efficacy as an add-on treatment of bipolar depression.

4. journalbipolardisorders.springeropen.com journalbipolardisorders.springeropen.com/articles/10.1186/s40345-025-00376-9

Effect of home-based transcranial direct current stimulation ... A course of home-based tDCS in bipolar depression was associated with an improvement in verbal learning, which appeared to be related to improvement in ...

5. brieflands.com brieflands.com/articles/jcp-142787

Effectiveness of Combined Treatment of Transcranial ... The combination of tDCS with routine medications can reduce depressive symptoms and improve bipolar symptoms.

6. journalbipolardisorders.springeropen.com journalbipolardisorders.springeropen.com/articles/10.1186/s40345-024-00352-9

Home-based transcranial direct current stimulation in bipolar ... The present study demonstrated high levels of acceptability, tolerability and safety for home-based tDCS in bipolar depression. Large-scale ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X19301044

Transcranial direct current stimulation for unipolar ... This study demonstrates that individuals receiving active tDCS for unipolar depression are at an increased risk of TEM compared to those receiving sham ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464394/

Efficacy and Safety of Transcranial Direct Current ... Regarding safety, active tDCS was well tolerated and all the adverse reactions reported were mild and limited to transient scalp discomfort.

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.969199/full

Efficacy and safety of daily home-based transcranial direct ... tDCS was not proven effective but was found to be both tolerable and safe in this home-based trial conducted for patients with bipolar I or II ...