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
Trial Overview
The study tests if deep Transcranial Magnetic Stimulation (dTMS) helps teens with major depression as an extra treatment alongside their current ones. It compares real dTMS against a sham (fake) procedure to see which is more effective.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants will receive active dTMS 5 sessions per day for 5 days
Sham dTMS 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12th month follow-up -reduction in depression symptoms from screening - they will then become eligible for and offered active, open-label treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
Utilization and outcomes of transcranial magnetic ...
In this real-world study of a large sample of patients with MDD, TMS patients experienced statistically significant improvements in depression ...
Clinical efficacy of deep transcranial magnetic stimulation ...
Efficacy, tolerability, and cognitive effects of deep transcranial magnetic stimulation for late-life depression: a prospective randomized controlled trial.
Efficacy and safety of deep transcranial magnetic ...
The secondary efficacy measures were response and remission rates at week 5. Response rates (PP set) were 38.4% for dTMS versus 21.4% for sham treatment (chi- ...
TMS Success Rates for Depression: Compare TMS Types
In a randomized sham-controlled trial, 82% of patients responded and 65% achieved remission after 30 sessions of dTMS. Even just 20 sessions ...
Deep TMS H1 Coil treatment for depression
For participants with data from at least 1 scale, 30 sessions of Deep TMS led to 81.6% response and 65.3% remission rate. 20 sessions led to 73.6% response and ...
Safety and efficacy of Deep TMS for adolescent depression ...
This study of 1257 adolescent and young adults patients with MDD found high response and remission rates and an onset of a clinical effect at 13 and 20 ...
Safety and efficacy of Deep TMS for adolescent depression ...
There was a significant decrease in depression severity after treatment (p<0.0001, Chi-square test; PHQ-9 categorical distribution). Anxiety symptoms also ...
Real world efficacy and safety of various accelerated deep ...
Accelerated Deep TMS with the H1 coil has an 80% response and 51% remission rate. · The six-month durability of accelerated Deep TMS is 93%. · Controlled dosing ...
Safety and Efficacy of Deep TMS for Late-Life Depression
Following 30 sessions of Deep TMS, there was a 79.4% response and 60.3% remission rate on the most rated scale. The outcomes on the PHQ-9 were ...
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mayoclinic.org
mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625Transcranial magnetic stimulation
Results. If rTMS works for you, your depression symptoms may improve or go away completely. Symptom relief may take a few weeks of treatment.
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