What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) that are similar to stereotactic electroencephalography-informed deep brain stimulation (stereo-EEG-informed DBS) include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), and deep brain stimulation (DBS). ECT can cause side effects such as memory loss, confusion, and physical side effects like headaches and muscle aches. TMS is generally well-tolerated but can lead to scalp discomfort, headaches, and, rarely, seizures. DBS involves surgical risks such as infection, bleeding, and hardware complications, along with potential side effects like mood changes and cognitive disturbances. Each of these treatments aims to modulate neural activity to alleviate depressive symptoms.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for Major Depressive Disorder (MDD), including electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). Deep brain stimulation (DBS), which involves the implantation of electrodes to send electrical impulses to specific brain regions, has also been explored for treatment-resistant depression, although it is primarily approved for Parkinson's disease and obsessive-compulsive disorder. These treatments aim to modulate neural activity to alleviate depressive symptoms, similar to the investigational stereotactic electroencephalography-informed deep brain stimulation (stereo-EEG-informed DBS) being studied for its potential to map and modulate the neural dynamics of socio-affective processing in MDD.

What other types of research exist?

Promising novel alternatives to stereo-EEG-informed DBS for Major Depressive Disorder patients include: 1) Electroconvulsive Therapy (ECT), which has shown efficacy in treatment-resistant depression and induces structural brain changes associated with therapeutic outcomes. 2) Transcranial Magnetic Stimulation (TMS), particularly deep TMS, which has been effective in reducing depressive relapses and can be used for maintenance treatment. 3) Transcranial Direct-Current Stimulation (tDCS), which has shown potential in enhancing neurocognition and mood in bipolar depression. 4) Vagus Nerve Stimulation (VNS), which has demonstrated long-term benefits in treatment-resistant depression, including reduced depressive symptoms and suicidality.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

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

0 / 13Eligibility criteria met

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.