Transcranial Direct Current Stimulation for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a home-based treatment called transcranial direct current stimulation (tDCS) for individuals with depression unresponsive to regular treatments. tDCS uses gentle electrical currents on the scalp to enhance brain flexibility and improve mood. Participants will use the device at home for two weeks, with remote guidance, to assess its impact on mood and brain activity. Individuals diagnosed with major depressive disorder who haven't responded to at least one antidepressant may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for depression.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it does mention that participants who require a benzodiazepine dose greater than lorazepam 2 mg/day are excluded, which might imply some restrictions on medication use.
What prior data suggests that transcranial direct current stimulation is safe for treating depression?
Research has shown that spaced transcranial direct current stimulation (tDCS) is safe and well-tolerated for treating depression. In earlier studies, patients found it manageable and experienced significant improvements in their depressive symptoms. tDCS is a non-invasive method that uses gentle electrical currents to stimulate the brain. This technique is generally considered safe, with some users reporting mild side effects like skin irritation or tingling. Patients can self-administer it at home with supervision, which studies have proven to be practical and effective. Overall, the safety of tDCS makes it a promising option for those seeking new ways to manage their depression.12345
Why are researchers excited about this trial?
Researchers are excited about Spaced Transcranial Direct Current Stimulation (tDCS) because it offers a new, non-invasive way to treat major depressive disorder (MDD) through direct electrical stimulation of the brain. Unlike traditional medications like SSRIs or therapy-based approaches, tDCS enhances neuroplasticity, potentially leading to more effective and faster outcomes. This method is also unique because it's self-administered at home, with multiple short sessions in a single day, making it a more flexible and potentially cost-effective option for patients.
What evidence suggests that transcranial direct current stimulation is effective for depression?
Studies have shown that transcranial direct current stimulation (tDCS), which participants in this trial will receive, can improve mood in people with depression. In some cases, depression symptoms improved by about 30% to 40% after treatment. This method applies a gentle electrical current to the head, helping the brain adapt and change. Research also shows that tDCS is a safe and well-tolerated treatment option. Although the improvements are modest, they offer hope for those who have not found relief with other therapies.14678
Are You a Good Fit for This Trial?
This trial is for individuals with depression, including Major Depressive Disorder, who haven't found relief with standard treatments. Participants will self-administer a brain stimulation therapy at home under supervision.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive at-home transcranial direct current stimulation (tDCS) for depression over a 2-week period with daily weekday treatments
Follow-up
Participants are monitored for safety, effectiveness, and changes in mood and brain activity after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Spaced Transcranial Direct Current Stimulation
Trial Overview
The study tests the safety and effectiveness of spaced transcranial direct current stimulation (tDCS) as an at-home treatment for depression over two weeks, involving daily sessions supervised remotely.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. tDCS sessions will be self-administered at home under the supervision of a trained clinical research coordinator. Each treatment day will consist of five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours per day. Other Names: * tDCS * Soterix Medical miniCT
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Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Citations
Spaced Transcranial Direct Current Stimulation for ...
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct ...
Spaced Transcranial Direct Current Stimulation for ...
In terms of clinical efficacy, the effects of tDCS were only modest, with improvements of approximately 30% and 40% in depression scores 3 and 6 ...
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The Soterix Medical 1x1-CT is the only tDCS stimulator allowing for both true double blind of experienced investigators and for simple operation by new users.
Transcranial Direct Current Stimulation for Depression
Also called a data safety and monitoring board, or DSMB. Early ... Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder.
Spaced Transcranial Direct Current Stimulation for Major ...
The protocol was feasible, safe, and well-tolerated and led to significant reductions in depressive symptoms. These results will need to be ...
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