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Neurostimulation

Therapeutic Neuromodulation for Depression

N/A
Waitlist Available
Led By David Spiegel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female, between the ages of 18 and 80 at the time of screening
Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week post-treatment-initiation
Awards & highlights

Study Summary

This trial will study a new treatment using electric pulses to reduce depression symptoms in people who have not been helped by other treatments.

Who is the study for?
This trial is for adults aged 18-80 with Major Depressive Disorder who haven't responded to standard treatments and have a MADRS score of ≥20. Participants must be TMS naive, in good health, agree to lifestyle considerations, and females must use effective contraception. Exclusions include metal implants that interfere with MRI or rTMS, seizure history, psychotic/bipolar disorders, substance abuse, severe personality disorder, recent suicide attempt or ECT without response.Check my eligibility
What is being tested?
The study tests an innovative neurostimulation method called accelerated intermittent theta burst stimulation (aiTBS) targeting two brain regions: DMPFC & DLPFC. It aims to alleviate symptoms of anhedonia in treatment-resistant depression by comparing the effects of aiTBS on these areas.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from similar neuromodulation treatments can include headache or discomfort at the stimulation site. There may also be risks associated with repetitive Transcranial Magnetic Stimulation (rTMS), such as seizures or changes in mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been diagnosed with Major Depressive Disorder and am currently experiencing a major depressive episode.
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My antidepressant dose has been stable for 6 weeks and I agree to keep it the same during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week post-treatment-initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-treatment-initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation

Trial Design

2Treatment groups
Active Control
Group I: Active TBS-DLPFCActive Control1 Intervention
The active group will receive theta-burst TMS DLPFC stimulation.
Group II: Active TBS-DMPFCActive Control1 Intervention
The active group will receive theta-burst TMS DMPFC stimulation.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,950 Total Patients Enrolled
David Spiegel, MDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
1,637 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation admit participants aged twenty or older?

"This clinical trial stipulates that the minimum age of participants must be 18, while the maximum age is set at 80 years old."

Answered by AI

Is there a possibility for me to join this clinical examination?

"For admittance to this medical trial, applicants must have major depressive disorder and be within the age range of 18-80 years old. A total of 100 patients can enroll in the clinical study."

Answered by AI

Are there currently any open enrollment opportunities for this experiment?

"As detailed on clinicaltrials.gov, this research endeavour is no longer recruiting participants; the initial posting was seen September 15th 2023 and the last update occurred three days later. Fortunately, there are 1379 other studies actively searching for volunteers at present."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve been on just about every antidepressant out there… since 1996. Desperate for help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression
David Spiegel 2023. "Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052137.
All > Transcranial Magnetic Stimulation
~50 spots leftby Oct 2024
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