Empower: tDCS for Major Depressive Disorder at Home

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

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether the Flow FL-100 tDCS device, which sends small electrical currents to the brain, is effective for people with major depressive disorder. Participants will use the device at home for several sessions over a few months without supervision. The goal is to see if this device can help improve their mood and reduce depression symptoms. Transcranial direct current stimulation (tDCS) has been studied extensively and shown potential efficacy in treating depression.

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 data supports the effectiveness of the treatment High Definition Transcranial Direct Current Stimulation (HD-tDCS)?

Research shows that transcranial direct current stimulation (tDCS), including its high-definition version (HD-tDCS), can modify brain functions and has been studied for various conditions like pain, Parkinson's disease, and depression. It has shown benefits in patients with brain injuries, suggesting potential effectiveness in modulating brain activity. ^{1 2 3 4 5}

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

Transcranial direct current stimulation (tDCS) is generally considered safe with mild and temporary side effects like itching, tingling, and headaches. However, there are warnings that it could potentially cause serious conditions, and more research is needed to fully understand its safety, especially in vulnerable groups like children and the elderly. ^{2 6 7 8 9}

How does High Definition Transcranial Direct Current Stimulation (HD-tDCS) differ from other treatments?

HD-tDCS is unique because it uses specialized small electrodes to provide more precise targeting of specific brain areas, potentially leading to more effective neural modulation compared to conventional tDCS. It is a non-invasive treatment that can increase brain activity in targeted areas, and it has been shown to be well-tolerated with minimal side effects. ^{1 2 3 10 11}

Eligibility Criteria

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

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

Treatment Details

Interventions

• Sham Transcranial direct current stimulation
• Transcranial direct current stimulation

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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]

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]

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]

References

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

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]

2. United States 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. [2023]

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

Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA. [2022]

4. France pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

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

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

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

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

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

A pilot study on effects of 4×1 high-definition tDCS on motor cortex excitability. [2022]

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

Validating a Sham Condition for Use in High Definition Transcranial Direct Current Stimulation. [2019]