Transcranial Magnetic Stimulation for Depression
(IMPACT-D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether deep Transcranial Magnetic Stimulation (dTMS) can assist hospitalized adolescents with major depressive disorder (MDD). The researchers aim to determine if dTMS is safe, practical, and effective in reducing depression symptoms. Participants will receive either the real dTMS treatment or a sham (fake) version for comparison. Teens aged 14 to 18, diagnosed with moderate to severe depression and able to explain the study's details, may be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in adolescent mental health.
Will I have to stop taking my current medications?
No, you don't have to stop taking your current medications to participate in this trial.
What prior data suggests that deep Transcranial Magnetic Stimulation is safe for adolescents with major depressive disorder?
Research has shown that deep Transcranial Magnetic Stimulation (dTMS) is generally safe for people with depression. In one study involving 1,257 adolescents and young adults with major depressive disorder (MDD), dTMS significantly reduced depression symptoms. Many participants experienced improvement or complete relief from their symptoms.
Another study found a noticeable decrease in depression severity after dTMS treatment, suggesting it can effectively lessen symptoms. Importantly, these studies did not report any major safety concerns, indicating that serious side effects were rare or absent.
Overall, dTMS is considered well-tolerated and helpful in reducing depression symptoms. For those considering joining a trial, this information suggests that dTMS could be a safe option.12345Why are researchers excited about this trial's treatment?
Transcranial Magnetic Stimulation (TMS) for depression is unique because it offers a non-invasive approach to treating depression by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional treatments like antidepressants or psychotherapy, Deep TMS (dTMS) can target specific brain regions more directly and with fewer side effects. Researchers are particularly excited about dTMS because it has the potential to provide rapid relief, with some patients experiencing benefits within days rather than the weeks typically required by medications. This makes dTMS a promising option for those who haven't responded well to conventional treatments.
What evidence suggests that deep Transcranial Magnetic Stimulation is effective for major depressive disorder?
Research has shown that deep Transcranial Magnetic Stimulation (dTMS) can help treat major depressive disorder (MDD). In one study, 82% of patients showed improvement, and 65% experienced complete relief from symptoms after 30 sessions. Another study found that 38.4% of people responded to dTMS, compared to only 21.4% who received a sham treatment. In this trial, participants will receive either active dTMS or a sham-controlled treatment. These results indicate that dTMS can significantly reduce depression symptoms compared to no real treatment. Overall, these findings suggest that dTMS could be a promising option for those dealing with depression.678910
Who Is on the Research Team?
Rana Elmaghraby, MD
Principal Investigator
Cincinnati Childrens Hospital Medical Center
Are You a Good Fit for This Trial?
This trial is for English-speaking adolescents aged 14-18 who are hospitalized with major depressive disorder and have moderate to severe depression. They must be able to understand the study and give informed consent. Those with a recent drug trial participation, active psychosis, immediate suicide risk, or conditions that make TMS unsafe (like epilepsy or metal implants) can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham dTMS 5 sessions per day for 5 days during hospitalization
Follow-up
Participants are monitored for safety, tolerability, and changes in depressive symptoms, suicidal ideation, and time to psychiatric readmission
Open-label extension (optional)
Participants in the sham group who do not show significant treatment response by the 12th month follow-up are offered active, open-label treatment
What Are the Treatments Tested in This Trial?
Interventions
- Deep Transcranial Magnetic Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor