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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
Must not have
Medical contraindication to surgery such as infection
High blood pressure and evidence of cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a new method to help patients with severe epilepsy and depression. It records and stimulates specific brain areas to better understand and improve social and emotional brain functions.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have surgery due to a medical issue like an infection.
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I have high blood pressure and heart disease.
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I regularly use blood thinners that can't be safely stopped.
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I have a health condition that makes surgery risky for me.
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I have a history of seizures, bleeding in the brain, or am at high risk for seizures.
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I have bipolar disorder with rapid changes in mood and was hospitalized for a manic episode in the last 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evoked potentials arising from stimulation.
Number of streamlines connecting between intracranial stimulation volume and recording volumes.
Secondary study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuromodulation treatments like repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), and deep brain stimulation (DBS) work by altering neural activity in specific brain regions implicated in mood regulation. rTMS uses magnetic fields to stimulate nerve cells in the prefrontal cortex, enhancing neural connectivity and plasticity. ECT induces controlled seizures through electrical currents, leading to changes in brain chemistry that can rapidly alleviate severe depressive symptoms. DBS involves the implantation of electrodes that deliver electrical impulses to targeted brain areas to modulate dysfunctional neural circuits. Understanding these mechanisms is crucial for MDD patients as it highlights the potential for targeted treatments to correct specific neural dysfunctions, offering hope for those who have not responded to traditional pharmacotherapy.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,432 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
~40 spots leftby Mar 2027