Transcranial Direct Current Stimulation for Depression

No longer recruiting at 1 trial location

Overseen By Cynthia Fu, Phd MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Flow Neuroscience AB

Must be taking: Antidepressants

Must not be taking: Benzodiazepines, Epileptics

Disqualifiers: Mania, Psychosis, Epilepsy, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a brain stimulation device called the Flow FL-100 tDCS (Transcranial Direct Current Stimulation) can effectively treat major depressive disorder (MDD) when used at home. Participants will receive either active stimulation or a sham (inactive) version over several weeks to assess which is more effective. The trial seeks individuals with MDD who have been on a stable antidepressant regimen or no medication for at least six weeks and have access to a smartphone and reliable internet. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance at-home treatment options for MDD.

Do I need to stop my current medications to join the trial?

You can continue taking your current antidepressant medication if it has been stable for at least 6 weeks before joining the trial. If you are not on any antidepressants, you do not need to start them for the trial.

What prior data suggests that the Flow FL-100 tDCS device is safe for treating major depressive disorder?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. Studies have found no serious side effects, such as brain tissue injury, linked to tDCS. This non-invasive technique uses a small electric current to stimulate the brain and has been used safely in many situations. Overall, tDCS is considered a safe option for those considering participation in clinical trials for major depressive disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for major depressive disorder, like antidepressants and psychotherapy, can take weeks to show effectiveness and often require clinical visits. But transcranial direct current stimulation (tDCS) offers a unique approach by using a low electrical current to stimulate brain activity directly, and it can be conveniently administered at home. Researchers are excited about this method because it could provide a quicker response time compared to traditional therapies and empower patients by allowing them to manage their treatment in a comfortable, familiar setting. Additionally, the use of sham stimulation in trials helps ensure the effects are genuinely due to tDCS, providing a clearer picture of its potential benefits.

What evidence suggests that the Flow FL-100 tDCS device is effective for major depressive disorder?

Research has shown that transcranial direct current stimulation (tDCS), a treatment participants in this trial may receive, can help with depression. A review of several studies found that tDCS noticeably reduced symptoms of depression, meaning people using tDCS felt better compared to those who didn't. Another study suggested that personalized tDCS could be a quick and safe way to treat moderate depression. These findings indicate that tDCS might be a promising option for people with major depressive disorder. Participants in this trial may also receive sham stimulation, which serves as a comparator to evaluate the effectiveness of active tDCS. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.

Be willing and able to comply with all study procedures.

Subject agrees to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study.

Exclusion Criteria

Are in a current state of mania, as determined by the YMRS or psychosis, as determined by the MINI.

Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.

Considered to have treatment resistant depression as defined by inadequate clinical response to 2 or more trials of antidepressants at an adequate dose and duration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Treatment

Participants perform up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase

10 weeks

Open-label Treatment

Participants perform 30 more tDCS sessions during an unblinded open-label phase

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Transcranial direct current stimulation
• Transcranial direct current stimulation

How Is the Trial Designed?

Group I: Active stimulation Active Control 1 Intervention

Active stimulation at 2mA

Group II: Sham stimulation Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Flow Neuroscience AB

Lead Sponsor

Trials

1

Recruited

170+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

University of East London

Collaborator

Trials

12

Recruited

980+

Published Research Related to This Trial

High-Definition transcranial Direct Current Stimulation (HD-tDCS) significantly increased cortical excitability in the motor cortex, as evidenced by enhanced motor evoked potential (MEP) amplitudes after 20 minutes of stimulation at 1 mA.

The stimulation was well tolerated by participants, with only mild, transient sensations reported, indicating a favorable safety profile for this non-invasive neuromodulatory technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on effects of 4×1 high-definition tDCS on motor cortex excitability. Caparelli-Daquer, EM., Zimmermann, TJ., Mooshagian, E., et al.[2022]

Optimized high-definition montages for transcranial direct current stimulation (tDCS) can increase stimulation intensity by an average of 0.3 V/m compared to unoptimized montages, which is crucial for targeting areas beneath skull defects.

Large skull defects with titanium or acrylic plates can reduce stimulation intensity by about 80%, while smaller defects filled with cerebrospinal fluid or scar tissue can increase stimulation intensity by about 200%, highlighting the importance of individual anatomical considerations in tDCS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. Guillen, A., Truong, DQ., Datta, A., 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]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.

HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Transcranial direct current stimulation (tDCS) is a noninvasive technique that can significantly alter brain functions and has been studied in 340 clinical articles for various conditions, including depression, pain syndromes, and neurodegenerative diseases.

The review provides a comprehensive overview of the clinical applications of tDCS, detailing factors such as study design, sample size, and stimulation parameters, which can help guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). Lefaucheur, JP.[2022]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36307858/

High-definition transcranial direct current stimulation (HD ... This randomized control trial aims at assessing the efficacy of HD-tDCS on ameliorating the depressive, cognitive and anxiety symptoms, and improving the daily ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X24000713

Results from a randomized, double-blind, controlled trial Despite being safe and easily accessible, transcranial direct current stimulation (tDCS) lacks extensive substantiation supporting its efficacy in treating OCD.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838763

Personalized High-Definition Transcranial Direct Current ... Overall, our findings demonstrate the clinical potential of personalized HD-tDCS as a safe and fast-acting antidepressant therapy for moderate ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11345433/

Immediate and long-term efficacy of transcranial direct current ... Overall, the results of meta-analysis indicated that tDCS had a high effect in improving specific symptoms (SMD = −0.73, 95% CI: −1.09 to −0.37) ...

5. nature.com nature.com/articles/s41598-025-09304-4

Effects of high-definition transcranial direct current ... HD-tDCS on the DMPFC is effective in sleep promotion and daily sleepiness recovery in patients with chronic insomnia. These findings demonstrate ...

6. neuromodec.org neuromodec.org/what-is-transcranial-direct-current-stimulation-tdcs/

What is transcranial Direct-Current Stimulation (tDCS)? Transcranial Direct-Current Stimulation (tDCS) is a portable, wearable brain stimulation technique that delivers a low electric current to the scalp.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X18301475

Tolerability and blinding of 4x1 high-definition transcranial ... Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06241963

High Definition Transcranial Direct Current Stimulation (HD ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...