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Deep Brain Stimulation

Deep Brain Stimulation for Depression

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response
Men and women (non-pregnant) between ages 22 and 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial will provide unique opportunities for researchers to study how the brain processes social and emotional information by recording from patients with treatment-resistant depression and epilepsy.

Who is the study for?
This trial is for men and women aged 22-70 with treatment-resistant depression or epilepsy, who are undergoing intracranial electrode placement. Participants must have a stable mental state, no drug abuse, no severe medical conditions that could interfere with surgery, and not be pregnant. They should have tried multiple depression treatments without success.Check my eligibility
What is being tested?
The study tests 'Directional Deep Brain Stimulation' (DBS) using advanced brain recording techniques in patients with resistant epilepsy and depression to understand how the brain processes social and emotional signals. It aims to improve socio-emotional functions by mapping these neural dynamics.See study design
What are the potential side effects?
Potential side effects of DBS may include discomfort at the stimulation site, headache, dizziness, changes in mood or behavior, muscle contractions or tingling sensations due to electrical impulses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had at least 6 weeks of psychotherapy without lasting improvement.
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I am between 22 and 70 years old and not pregnant.
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My depression symptoms are severe, scoring 27 or higher on the MADRS.
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I have been diagnosed with major depression as my main health issue.
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I have a long-term illness lasting over 2 years or have had it come back at least twice.
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I have tried at least four depression treatments from two categories without success.
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I have undergone Electroconvulsive Therapy (ECT) before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evoked potentials arising from stimulation.
Number of streamlines connecting between intracranial stimulation volume and recording volumes.
Secondary outcome measures
Match score between spectral band power matrix of desired state and stimulation-evoked state.
Spectral band power during mood-relevant cognitive task.
Spectral band power following applied stimulation.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TRDExperimental Treatment1 Intervention
Group II: EMUActive Control1 Intervention
Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,128 Total Patients Enrolled

Media Library

Directional Deep Brain Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05418894 — N/A
Major Depressive Disorder Research Study Groups: EMU, TRD
Major Depressive Disorder Clinical Trial 2023: Directional Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05418894 — N/A
Directional Deep Brain Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05418894 — N/A

Frequently Asked Questions

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

What key goals is this research project aiming to achieve?

"This trial, to be conducted over the course of 8 weeks, aims to measure Aim 1.2. Secondary outcomes include determining the electrophysiological functions of affective salience networks through power spectral density during mood-relevant cognitive activities; exploring neural function changes due to stimulation applied across target structures with varying current direction, frequency, amplitude and pulse widths; and assessing correlations between stimulated states versus desirable natural or induced positive mood states using template matching techniques such as spatiotemporal correlation matrix decomposition and machine learning dimensionality reduction."

Answered by AI

Am I eligible to participate in this scientific experimentation?

"This clinical trial is enrolling 84 men and women aged 22 to 70 who are currently experiencing an aura. In addition, they must have failed four adequate depression treatments from at least two different categories; previously tried ECT (with partial or un-sustained response); a MADRS score of 27 one week prior to surgery; had exposure to psychotherapy without sustained relief for 6 weeks or more; experienced MDE for 24 months with the current episode lasting over 12 months; been diagnosed with major depressive disorder as their primary disorder according to DSM-5 criteria via SCID-5 assessment; and achieved a HDRS17 score greater than 20"

Answered by AI

What is the aggregate number of participants in this trial?

"Affirmative. According to clinicaltrials.gov, this research is currently enrolling participants and was first posted on April 1st 2022 with its most recent update occurring June 16th 2022. Eighty-four patients will be accepted at a single medical facility for the study."

Answered by AI

Does the research allow for participants of all ages or are there age restrictions?

"This trial is enrolling those aged 22 or above, and below the age of 70."

Answered by AI

Are there opportunities to join this investigation at present?

"Affirmative. Per the records hosted on clinicaltrials.gov, this research project is still enrolling participants. It was posted on April 1st 2022 and updated lastly June 16th of this year; 84 volunteers are sought at one medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’ve tried several different brands and it doesn’t work.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
Kelly Bijanki 2022. "Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05418894.
All > Depression Houston > Epilepsy
~50 spots leftby Mar 2027
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