Device: Directional Deep Brain Stimulation for Aura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
Aura+2 More
Device: Directional Deep Brain Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The overall goal of this study is to map the spatiotemporal dynamics of social affective processing and to examine selective modulation of these dynamics in humans undergoing invasive intracranial monitoring for treatment-resistant epilepsy and depression. Pursuing this signal from a novel platform with invasive intracranial recording electrodes provides much-needed spatial and temporal resolution to characterize the neural dynamics of socio-affective processing. The investigators will leverage first-in-human intracranial neural recording opportunities created by a novel therapeutic platform termed "stereotactic electroencephalography-informed deep brain stimulation" (stereo-EEG-informed DBS), as well as the powerful platform of intracranial stereotactic recording and stimulation in patients undergoing epilepsy surgical evaluation at Baylor College of Medicine. The sEEG-informed DBS trial provides unique opportunities for intracranial recording of affect-relevant network regions in patients with treatment-resistant depression (TRD). Recordings in identical regions in epilepsy patients who themselves often demonstrate mild-moderate depressive symptoms will provide a wide dynamic range across the symptom spectrum. To provide critical data on the spatiotemporal dynamics of socio-affective processing the investigators will leverage these two human intracranial recording and stimulation cohorts to study the precise structural, functional, and causal properties of the affective salience network. Greater understanding of the social processing circuitry mediated by the affective salience network may be used to drive therapeutic innovation, pioneering a new paradigm that improves socio-emotional function across a wide variety of neuropsychiatric conditions. The results from this proposal have the potential to improve the lives of patients with dysfunction in social affective processing, with implications for a wide range of neuropsychiatric diseases.

Eligible Conditions

  • Aura
  • Unipolar Depression

Treatment Effectiveness

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: up to 12 weeks

up to 12 weeks
Aim 2
Aim 3.2
Match score between spectral band power matrix of desired state and stimulation-evoked state.
Spectral band power during mood-relevant cognitive task.
up to 8 weeks
Aim 1.1
Aim 1.2
Aim 3.1
Evoked potentials arising from stimulation.
Number of streamlines connecting between intracranial stimulation volume and recording volumes.
Spectral band power following applied stimulation.

Trial Safety

Trial Design

2 Treatment Groups

EMU
1 of 2
TRD
1 of 2
Active Control
Experimental Treatment

84 Total Participants · 2 Treatment Groups

Primary Treatment: Device: Directional Deep Brain Stimulation · No Placebo Group · N/A

TRD
Device
Experimental Group · 1 Intervention: Device: Directional Deep Brain Stimulation · Intervention Types: Device
EMUNoIntervention Group · 1 Intervention: EMU · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks
Closest Location: Baylor College of Medicine · Houston, TX
Photo of baylor college of medicine 1Photo of baylor college of medicine 2Photo of baylor college of medicine 3
2003First Recorded Clinical Trial
0 TrialsResearching Aura
802 CompletedClinical Trials

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
910 Previous Clinical Trials
5,981,682 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Failure to respond to a minimum of four adequate treatments from at least two different treatment categories (e.g.
You have previously received ECT (or another intervention) that was partial or un-sustained.
You have had a lifetime of psychotherapy without sustained response.
You have a current MDE of at least 24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode >12 months).
You have a diagnosis of major depression disorder (MDD) as the primary diagnosis.
You have a score of 16 or more on the Hamilton Depression Rating Scale-17 item (HDRS17).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.