Transcranial Magnetic Stimulation for Depression

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuroQore Inc.

Disqualifiers: Epilepsy, Substance abuse, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions. The goal of this clinical trial is to evaluate the safety and effectiveness of an accelerated but shortened TMS dosing regimen for adults with MDD aged 22-85. Participants in this study will be subjected to the same 19-minutes treatment session, but three times on the same day, and only for one day. This will greatly reduce the logistical burden of completing the therapy regime.

Eligibility Criteria

Adults aged 22-85 with Major Depressive Disorder (MDD) can participate in this trial. The study is testing a new, accelerated TMS treatment schedule to see if it's as safe and effective as the standard regimen.

Inclusion Criteria

My depression didn't improve with previous medication.

MADRS score > 20 at baseline and immediately prior to the day of treatment

I am between 22 and 85 years old.

Exclusion Criteria

I have no health issues that prevent me from using rTMS for depression.

Pregnancy as determined by serum/urine pregnancy test

I have a history of seizures or epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive three 19-minute rTMS treatment sessions in one day with 60 minutes rest between sessions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

2 visits (in-person)

Treatment Details

Interventions

• Accelerated rTMS treatment

Trial Overview The trial is studying an accelerated version of Transcranial Magnetic Stimulation (TMS) therapy for MDD. Instead of daily sessions over six weeks, participants receive three 19-minute sessions in one day.

Participant Groups

Group I: Accelerated Protocol Experimental Treatment 1 Intervention

1 Day x 3 Sessions treatment protocol, with 60 minutes rest between sessions. Each session is a 19-minutes rTMS treatment.

Who Is Running the Clinical Trial?

NeuroQore Inc.

Lead Sponsor

Trials

3

Recruited

90+

Makromed Inc.

Collaborator