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Procedure

Brain Stimulation for Depression

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medication-refractory epilepsy requiring phase II monitoring

Men and women, ages 18 to 65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes

Awards & highlights

Study Summary

This trial aims to identify markers of brain activity to better understand how TMS treatments work to help treat depression & other psychiatric disorders.

Who is the study for?

This trial is for men and women aged 18 to 65 who have medication-resistant epilepsy needing detailed monitoring, and are able to understand the study's risks to give informed consent. It excludes those with major neurological disorders besides epilepsy.Check my eligibility

What is being tested?

The study tests how repetitive brain stimulation affects the brain using TMS (a noninvasive treatment for depression) and intracranial electrodes. It aims to identify precise brain activity markers that can enhance TMS effectiveness for treating depression.See study design

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headaches, lightheadedness, or seizures in rare cases. Intracranial electrode placement involves surgical risks like infection, bleeding, or damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My epilepsy does not improve with medication and needs special monitoring.

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I am between 18 and 65 years old.

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I have epilepsy but no other major neurological disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TMS-iEEG change after one TBS session

Secondary outcome measures

ES-iEEG change after one TBS session

ES-iEEG change between two sequential TBS sessions

TMS-iEEG change between two sequential TBS sessions

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: TBS via direct electrical stimulationActive Control1 Intervention

Group II: TBS via transcranial magnetic stimulationActive Control1 Intervention

Group III: Sham TBS via direct electrical stimulationPlacebo Group1 Intervention

Group IV: Sham TBS via transcranial magnetic stimulationPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,394 Previous Clinical Trials

17,341,561 Total Patients Enrolled

16 Trials studying Epilepsy

1,209 Patients Enrolled for Epilepsy

Massachusetts General HospitalOTHER

2,932 Previous Clinical Trials

13,198,446 Total Patients Enrolled

8 Trials studying Epilepsy

589 Patients Enrolled for Epilepsy

University of IowaOTHER

446 Previous Clinical Trials

879,453 Total Patients Enrolled

1 Trials studying Epilepsy

335 Patients Enrolled for Epilepsy

Frequently Asked Questions

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

Are there any opportunities for participants in this clinical trial?

"It appears that clinicaltrials.gov does not indicate this medical trial is presently accepting patients; the original posting was on September 1st, 2023 and the latest edit occurred on November 21st, 2023. Despite this, there are still 1148 additional trials actively recruiting volunteers currently."

Answered by AI

Who meets the necessary criteria to participate in this medical study?

"This trial is open to both males and females, aged 18-65 who have been diagnosed with epilepsy that does not respond to medication. Additionally, participants must be of intellectual capacity to understand the risks associated with taking part in this medical study as well as provide informed consent. There can also be no current or prior major neurological disorders besides epilepsy present for eligibility."

Answered by AI

Does this research trial include individuals aged 60 or older?

"This trial is available for persons aged 18 to 65. Separately, there are 226 clinical trials designed for minors and 814 specifically tailored for those above the age of retirement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans

Corey Keller 2023. "Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996900.

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