ONE-D TMS + D-Cycloserine for Depression and Concussion
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment combining transcranial magnetic stimulation (TMS) with the medication d-cycloserine to assist female athletes with both depression and a history of concussions. Researchers aim to determine if this combination can improve symptoms of both conditions by targeting brain connectivity patterns. The trial includes female athletes, whether recreational or professional, who have experienced a concussion and have moderate depression unresponsive to standard antidepressants. Participants may experience a decrease in their depression and concussion symptoms. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative approach.
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 taking ototoxic medications (drugs that can damage the ear), you cannot participate in the trial.
What prior data suggests that the ONE-D TMS treatment is safe for female athletes with a history of concussion and depression?
Previous studies have shown that the ONE-D TMS treatment combined with D-cycloserine is safe and well-tolerated. Research indicates that this method effectively treats depression, with many individuals responding positively. For instance, one study found that nearly 90% of participants felt better within a week when using ONE-D TMS with D-cycloserine. Another study demonstrated that this treatment was not only effective but also easy for patients to manage. These findings suggest that the treatment is generally safe, with few side effects reported.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for depression and concussion, which typically involve medications like antidepressants or therapy, the ONE-D TMS treatment uses a unique approach. It combines transcranial magnetic stimulation (TMS) with a single dose of d-cycloserine, a medication that acts as a neural primer. This combination not only targets the brain's neural circuits more directly but also may enhance the brain's plasticity, potentially leading to faster and more effective results. Researchers are excited because this method could offer a new avenue for those who haven't found success with existing therapies.
What evidence suggests that the ONE-D TMS treatment could be effective for depression and concussion?
Research has shown that repetitive transcranial magnetic stimulation (rTMS) can improve depression symptoms following a traumatic brain injury. Studies indicate that 50-60% of patients experience significant improvement, and 30-40% fully recover from depression after treatment with rTMS regimens like ONE-D. A large review of studies found that 36% of people receiving active TMS treatments went into remission, compared to just over 8% who did not receive active treatment. In this trial, participants will receive the ONE-D protocol, which includes a dose of D-cycloserine. Additional research suggests this combination may effectively treat depression and could also alleviate symptoms related to concussions.13678
Who Is on the Research Team?
Sara Gould, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for female athletes aged 18-65 who have both moderate or worse depression (PHQ-9 score ≥10) and a recent concussion, and whose depression hasn't improved with at least 6 weeks of antidepressants. People can't join if they're pregnant, breastfeeding, male, have certain implants or medical conditions like epilepsy or bipolar disorder.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a one-day TMS treatment with pharmacologic neural priming using d-cycloserine and 20 sessions of theta-burst stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment with symptom inventories recorded at weeks 3, 6, and 12
What Are the Treatments Tested in This Trial?
Interventions
- ONE-D TMS Treatment
Trial Overview
The study tests a special TMS brain stimulation protocol called ONE-D combined with the medication d-cycloserine (125 mg) to see if it helps improve symptoms of both depression and concussion in female athletes. Participants will receive these treatments as part of the research.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants are treated with ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
Effect of repetitive transcranial magnetic stimulation on ... - PMC
Our results demonstrated that rTMS has a significant positive effect on post-TBI depression immediately after administration. Nevertheless, the effect size ...
Real-world effectiveness of a single-day regimen for ...
This retrospective case series reports outcomes for an optimized, neuroplasticity-enhanced depression (ONE-D) treatment regimen delivering 600-pulse iTBS (120 % ...
3.
cognitivefxusa.com
cognitivefxusa.com/blog/can-tms-treat-depression-in-one-day-one-d-treatment-explainedCan TMS Treat Depression in One Day? ONE-D Treatment ...
Studies show that approximately 50-60% of patients experience significant improvement, with about 30-40% achieving complete remission from ...
Utilization and outcomes of transcranial magnetic stimulation ...
Remission rates seen in the study were highest at the end of the TMS treatment course, with 19.1% of the TMS cohort experiencing remission at ...
The role of transcranial magnetic stimulation in treating ...
Both 15 to 16 session and 30 to 38 session cohorts showed significant decreases in depression as measured by PHQ-9 following rTMS treatment. These findings ...
Efficacy of Adjunctive D-Cycloserine to Intermittent Theta- ...
Results of this randomized clinical trial suggest that adjunctive DCS may be a promising strategy for improving TMS treatment outcomes in MDD ...
Single-day accelerated TMS with D-cycloserine ...
We conducted a double-blind placebo-controlled trial examining whether DCS could enhance single-day accelerated intermittent theta-burst ...
Study Details | NCT07227103 | A Randomized, Double ...
When the AMPA one day (ONE-D) TMS protocol was combined with DCS, the measured response rate was 87% at one week. This trial will compare response and remission ...
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