Transcranial Alternating Current Stimulation for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called closed-loop transcranial alternating current stimulation (tACS) to determine its effectiveness in reducing symptoms of major depressive disorder. The study compares the effects of active tACS treatment with a sham treatment to assess its efficacy. This trial may suit individuals who have struggled with depression, have not found relief with antidepressants, and can maintain their current treatment routine. As an unphased trial, it offers participants a unique opportunity to contribute to pioneering research in depression treatment.
What prior data suggests that this closed-loop transcranial alternating current stimulation (tACS) device is safe for treating depression?
Research has shown that transcranial alternating current stimulation (tACS) is being explored as a potential treatment for depression. Although specific safety data for this exact tACS device is not available, information from similar brain stimulation methods can be considered.
For example, studies on other brain stimulation techniques, such as transcranial magnetic stimulation (TMS), have indicated that these treatments are generally safe. Some individuals might experience mild side effects, like headaches or scalp discomfort, but serious issues are rare. This suggests that tACS might also be safe, though more direct data on tACS itself is necessary.
Additionally, this trial is labeled as "Not Applicable" in terms of phase, indicating it might not yet have the safety information typically collected in earlier study phases. Therefore, while there is interest in using tACS for depression, further research is needed to fully understand its safety in humans.12345Why are researchers excited about this trial?
Researchers are excited about closed-loop transcranial alternating current stimulation (tACS) for depression because it offers a novel approach compared to traditional treatments like antidepressants and psychotherapy. Unlike medications that alter brain chemistry, tACS uses electrical currents to directly modulate brain activity, potentially reducing symptoms of depression with fewer side effects. Additionally, the closed-loop system of tACS can be tailored to an individual's brain activity, providing a more personalized and potentially more effective treatment option. This method might offer quicker relief, as it is designed to work over just a few days, compared to weeks or months for standard therapies.
What evidence suggests that this closed-loop tACS device is effective for reducing symptoms of depression?
Research has shown that closed-loop transcranial alternating current stimulation (tACS) may help improve symptoms of major depression. In this trial, participants may receive active closed-loop tACS, involving daily sessions for five consecutive days. One study found that people experienced significant improvement and a better quality of life after just five days of personalized treatment. Another study reported a substantial reduction in depression symptoms within two weeks, with the most improvement occurring in the first week. While not all research is definitive, these early results suggest that tACS could be an effective treatment for depression.678910
Who Is on the Research Team?
Mark George, MD
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
This trial is for adults age 22 or older with moderate to severe major depressive disorder who haven't found enough relief from at least one antidepressant, are currently in a depressive episode, and can follow the study schedule. Participants must be under care of a mental health provider and able to consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive closed-loop transcranial alternating current stimulation (tACS) daily for five consecutive days
Follow-up 1
Participants are monitored for safety and effectiveness at week 3
Follow-up 2
Participants are monitored for safety and effectiveness at week 5
Phase 2 Retreatment
Non-responders at week 3 receive a second dose of active CL-tACS for five consecutive days
Phase 2 Follow-up 1
Participants are monitored for safety and effectiveness at phase 2 week 3
Phase 2 Follow-up 2
Participants are monitored for safety and effectiveness at phase 2 week 5
What Are the Treatments Tested in This Trial?
Interventions
- Closed-loop transcranial alternating current stimulation (tACS)
Trial Overview
The study compares a closed-loop transcranial alternating current stimulation (tACS) device—a non-invasive brain stimulation technique—to a sham (inactive) treatment to see if it helps reduce depression symptoms. Participants are randomly assigned to either group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
An open label, second dose of Closed-loop individual alpha tACS daily for five consecutive days. Assignment to this arm occurs after participation in the closed label active or sham arms.
Closed-loop individual alpha tACS daily for five consecutive days.
Sham closed-loop individual alpha tACS daily for five consecutive days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulvinar Neuro, LLC
Lead Sponsor
Citations
Brain Stimulation Journal
Background: The effect of transcranial alternating current stimulation (tACS) on major depressive disorder (MDD) was not confirmed.
Brain Stimulation Improves Depression Symptoms, ...
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It demonstrated significant reductions in both depressive symptoms and SI within two weeks (all P < 0.05), predominantly in the first week.
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Responses to rapid-rate transcranial magnetic stimulation ...
rTMS showed a pattern of inhibitory and excitatory effects. This suggests that the spread might be due to the breakdown of inhibitory connections or the ...
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