High-Dose tDCS for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a higher dose of transcranial direct current stimulation (tDCS) is safe for people with depression. Participants will receive mild electrical stimulation through electrodes on their scalp to determine if it improves mood. The trial includes several sessions over five days, with researchers monitoring comfort and mood changes. It seeks participants who currently have depression and have struggled with it for some time (PHQ-9 greater than 9). As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for depression.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on medications that lower the seizure threshold, you may not be eligible to participate.
What prior data suggests that this technique is safe for people with depression?
Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with depression. Previous studies found tDCS to be as safe and acceptable as a sham (fake) treatment, meaning participants did not experience more side effects than those who received no real treatment. Even with higher doses, participants tolerated the treatment well.
A study on home-based tDCS treatment for depression also demonstrated its safety and tolerability, with no serious side effects. Another study with 71 participants showed that tDCS significantly improved mood without major safety concerns.
Overall, research supports the safety of tDCS for depression, even at higher doses. However, participants must be closely monitored during these treatments to ensure their comfort and safety.12345Why are researchers excited about this trial?
Transcranial Direct Current Stimulation (tDCS) is unique because it offers a non-invasive way to potentially treat major depressive disorder by directly stimulating the brain with electrical currents. Unlike traditional treatments like antidepressant medications and psychotherapy, which can take weeks to show results, this high-dose tDCS approach could offer faster relief by delivering targeted stimulation twice daily. Researchers are particularly excited about its potential to enhance brain function and mood with minimal side effects, setting it apart from more invasive or systemic treatments.
What evidence suggests that high-dose tDCS is effective for depression?
Research has shown that transcranial direct current stimulation (tDCS) can help with depression. In one study, people who received tDCS for 10 weeks showed more improvement in their depression symptoms than those who did not receive the treatment. Another study found that tDCS significantly improved mood in people with moderate to severe depression. A different real-world study confirmed that tDCS helped reduce symptoms in patients with major depressive disorder. This trial will specifically investigate the effects of high-dose tDCS, as these findings suggest that higher doses could be particularly effective for treating depression.12346
Who Is on the Research Team?
Clayton Olash, MD
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with Major Depressive Disorder, as confirmed by a specific diagnostic interview. They must have moderate to severe depression symptoms, be fluent in English, and able to give consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Initial participants receive dose-escalation tDCS (2 mA → 4 mA → 6 mA) with close monitoring for safety and skin integrity
Treatment
Participants receive high-dose tDCS at 6 mA twice daily for five consecutive weekdays
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of depressive symptoms, cognition, and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Direct Current Stimulation (tDCS)
Trial Overview
The study tests high-dose transcranial direct current stimulation (tDCS) on people with depression. It starts with increasing doses for safety checks and then continues with repeated sessions at the highest safe level over five days.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this single-arm, open-label pilot study will receive high-dose transcranial direct current stimulation (tDCS) for major depressive disorder. Each participant undergoes twice-daily 20-minute sessions at 6 mA for five consecutive weekdays (total of 10 sessions). The first three participants complete an in-lab dose-escalation safety run-in (2 mA → 4 mA → 6 mA on Day 1) with a Day 2 skin integrity check before continuing at 6 mA twice daily for the remaining days. All participants complete baseline, post-intervention, and 4-week follow-up assessments of depressive symptoms, cognition, and tolerability.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
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 ...
Transcranial Electrical Stimulation in Treatment of ...
Among tES modalities, tDCS was associated with a significant improvement in depressive symptoms among patients with DMC (SMD = −1.05; 95% CI, − ...
Personalized High-Definition Transcranial Direct Current ...
In this randomized clinical trial of 71 participants with moderate to severe depression, statistically significant mood improvement was observed ...
NCT07226011 | Accelerated High-Dose tDCS for Depression
Participants in this single-arm, open-label pilot study will receive high-dose transcranial direct current stimulation (tDCS) for major depressive disorder.
Reduction of symptoms in patients with major depressive ...
This real-world study showed good tolerability and a reduction of depressive symptoms in patients with MDD after tDCS treatment.
Safety and acceptability of transcranial direct current ...
Active tDCS is as acceptable and safe as sham in randomized clinical trials of MDD. · Higher tDCS doses did not affect the overall acceptability.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.