Transcranial Electrical Stimulation for Depression

Overseen By Caitlin Carroll, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: EEG-altering drugs

Disqualifiers: Neurologic disease, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 17

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a gentle brain treatment during sleep can boost deep sleep in individuals with moderate depression and improve their thinking skills and mood. Participants will wear a device that stimulates the brain during sleep (transcranial electrical stimulation) and a watch that tracks activity levels. Ideal candidates have moderate depression, report issues with thinking, and can participate in an overnight sleep study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance sleep and mental health.

Will I have to stop taking my current medications?

Yes, if you are currently taking medications that could affect brain activity or cognitive function, you may need to stop taking them to participate in this trial.

What prior data suggests that this device is safe for use during sleep?

Research has shown that transcranial electrical stimulation (TES) is generally safe and well-tolerated. Most people experience only mild side effects, such as tingling or mild headaches, with serious issues being rare. One study found that using TES at home with remote supervision was both effective and safe for treating depression. Although some risk exists with any treatment, past research indicates that TES maintains a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Electrical Stimulation (TES) is unique because it offers a non-invasive and potentially more convenient method for treating depression, especially compared to traditional options like antidepressants and psychotherapy. Unlike medications that can take weeks to show effects and may come with a range of side effects, TES is applied during sleep and might offer quicker results with fewer side effects. Researchers are excited about this treatment because it targets brain activity directly through gentle electrical currents, which could provide a new way to improve mood regulation without the need for daily medication or frequent therapy sessions.

What evidence suggests that transcranial electrical stimulation is effective for depression?

Research has shown that transcranial electrical stimulation (TES) can improve depression symptoms. Studies have found that TES, including transcranial direct current stimulation (tDCS), significantly boosts mood. One review found that people with depression who used TES had better results than those who did not. Another study showed that using tDCS at home for ten weeks reduced depression symptoms more effectively than not using it. These findings suggest that TES could be a promising option for people with depression. In this trial, all participants will receive transcranial electrical stimulation (TES) during sleep to further evaluate its effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Ruth Benca, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with depression who are interested in exploring if non-invasive brain stimulation can enhance their deep sleep. Participants must be willing to wear a device that records brain activity and delivers transcranial electrical stimulation during sleep, as well as an actigraphy watch to monitor activity levels.

Inclusion Criteria

Ability to complete overnight sleep study including placement of EEG leads

Ability to read and understand English

Moderate depression

Exclusion Criteria

Currently pregnant

I have severe trouble sleeping.

Previous adverse reaction to transcranial electrical stimulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Recording

Participants undergo up to three nights of baseline recordings using the WISP headband to ensure successful baseline measurements are recorded.

1 week

3 visits (in-person)

Treatment

Participants receive transcranial electrical stimulation (TES) nightly for two weeks, while wearing an actigraphy watch and keeping a sleep diary.

2 weeks

14 visits (in-person)

Follow-up

Participants are monitored for changes in sleep, cognitive performance, and mood symptoms after treatment.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Electrical Stimulation

Trial Overview The study tests whether Transcranial Electrical Stimulation (TES) during sleep can increase the amount of deep sleep in individuals with depression and if this leads to improvements in cognitive performance and mood. The intervention involves wearing a special device at night.

How Is the Trial Designed?

Group I: Transcranial Electrical Stimulation (TES) Experimental Treatment 1 Intervention

All participants will receive transcranial electrical stimulation (TES) during sleep

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12177679/

Transcranial Electrical Stimulation in Treatment of Depression This systematic review and meta-analysis evaluates outcomes of various transcranial electrical stimulation treatments in patients with major depressive disorder

2. nature.com nature.com/articles/s41591-024-03305-y

Home-based transcranial direct current stimulation ... In summary, a 10-week course of home-based active tDCS was associated with greater improvements in depressive symptoms, clinical response and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2324242625000129

Comparison of the efficacy of high-definition transcranial ... All groups demonstrated significant improvement in depressive symptoms and cognitive function. The rTMS group exhibited a significantly greater decrease in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40531534/

Transcranial Electrical Stimulation in Treatment of Depression In this systematic review and meta-analysis, tDCS was associated with improvement in depression among patients with DMC and DPC (with smaller benefits in MDD).

5. joghnp.scholasticahq.com joghnp.scholasticahq.com/article/77442-transcranial-direct-current-stimulation-as-an-adjuvant-in-the-improvement-of-symptoms-of-depression-a-quasi-experimental-design-study

Transcranial direct current stimulation as an adjuvant in ... Transcranial direct current stimulation is an effective therapeutic option in the reduction of depressive symptoms as an adjunct to pharmacological treatment.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835422

Transcranial Electrical Stimulation in Treatment of ... Meaning These findings suggest that tES is well-tolerated overall, with only mild to moderate adverse events; future studies should explore how ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25002074

A comparative analysis of technical data: At-home vs. in- ... This study investigates tDCS quality based on its technical parameters as well as safety of at-home and in-clinic tDCS applications comparing the data from two ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05172271

Transcranial Electric Stimulation Therapy (TEST) for ... It tests the hypothesis that Transcranial Electric Stimulation Therapy (TEST), an experimental brain stimulation therapy, can have an antidepressant effect.