Electrical Stimulation for Mental Health Conditions

(Stim_Con Trial)

Overseen By Rebekah Chatfield, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Inability to complete task, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Electrical Pulse Train Stimulation, Direct Brain Stimulation, and Deep Brain Stimulation for mental health conditions?

Deep brain stimulation, a type of electrical brain stimulation, has shown promising results for difficult-to-treat conditions like obsessive-compulsive disorder and major depressive disorder. It is considered safe, adjustable, and reversible, offering new hope for patients with severe psychiatric disorders. ^{1 2 3 4 5}

Is electrical stimulation generally safe for mental health conditions?

Research shows that deep brain stimulation (DBS) and electroconvulsive therapy (ECT) are generally safe when performed with proper precautions, with no permanent harm reported in cases studied. However, minor issues can occur, and surgical or hardware-related problems may affect quality of life. ^{6 7 8 9 10}

How does electrical stimulation differ from other treatments for mental health conditions?

Electrical stimulation, specifically deep brain stimulation, is unique because it involves implanting electrodes in the brain to deliver adjustable electric pulses, offering a reversible and customizable treatment option for severe psychiatric disorders that do not respond to traditional therapies like medication or psychotherapy. ^{1 2 3 4 11}

Research Team

Adam Goodman, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals with epilepsy who are undergoing standard-of-care (SOC) surgery evaluation and have the cognitive ability to perform tasks and understand instructions. Participants must have electrodes implanted in specific brain regions (amygdala and medial PFC) and be able to consent.

Inclusion Criteria

I understand and can sign the consent form.

Implanted electrodes in the amygdala and medial PFC regions

I can perform simple tasks and understand instructions.

Exclusion Criteria

I cannot complete the task.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-acquisition Stimulation

Single pulse stimulation delivered and measured prior to the rating task

20 minutes

1 visit (in-person)

Pavlovian Fear Conditioning

Participants perform the Pavlovian fear conditioning paradigm with stimulation applied at controlled time points

20 minutes

1 visit (in-person)

Post-acquisition Stimulation

Stimulation pulse trains delivered to assess changes in fronto-limbic connectivity and emotional response regulation

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stimulation and conditioning

4 weeks

Treatment Details

Interventions

• Electrical Pulse Train Stimulation

Trial Overview The study investigates how emotions are processed in the brain using a technique called stereoelectroencephalography (sEEG) combined with electrical pulse train stimulation. It involves behavioral tasks, neural recording, and direct brain stimulation before and after conditioning.

Participant Groups

Group I: Acquisition Stimulation Test Experimental Treatment 1 Intervention

Single pulse stimulation will be delivered and measured prior to the rating task. Next, subjects perform the Pavlovian fear conditioning paradigm. Participants will be asked to perform a rating task automated on a PC where they continuously update a rating bar using the touchpad to indicate their confidence that a static sound is about to occur on a moment-by-moment basis (0-not confident to 100-very confident). For the stimulation experiment, research staff will explain that electrical stimulation will be applied before the rating task, in isolation, as well as on some trials at controlled time points while the patient performs the rating task

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Deep brain stimulation (DBS) is a safe and adjustable therapy that uses implanted electrodes to deliver electrical impulses to specific brain areas, showing promise in treating severe psychiatric diseases that are resistant to other treatments.

Unlike traditional surgical methods that were destructive, DBS is reversible and can be tailored to individual patients, potentially improving their quality of life and reducing the burden of severe psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the treatment of severe, medically refractory obsessive-compulsive disorder. Sedrak, M., Wong, W., Wilson, P., et al.[2021]

Deep brain stimulation (DBS) has shown promise as a treatment for therapy-refractory obsessive-compulsive disorder (OCD) and major depressive disorder (MDD), with 286 patients studied across various trials.

While DBS for OCD has received FDA approval, the overall evidence for its efficacy in psychiatric disorders is limited due to small sample sizes and a lack of randomized controlled trials, making other indications still experimental.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Naesström, M., Blomstedt, P., Bodlund, O.[2022]

Deep brain stimulation (DBS) is a promising and reversible treatment option for psychiatric disorders like obsessive-compulsive disorder, Tourette's syndrome, and major depressive disorder, with low risk of complications.

DBS allows for adjustable treatment parameters post-surgery, which may lead to rapid responses in patients, prompting a reevaluation of the underlying mechanisms of psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in psychiatric disorders]. Denys, D.[2008]

Deep brain stimulation (DBS) shows promising efficacy in treating various psychiatric disorders, including treatment-resistant depression and obsessive-compulsive disorder, based on a review of existing literature.

The method has a low risk of adverse effects, making it a potentially safe option for patients with difficult-to-treat psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in psychiatry. Jesić, MP., Zivanović', O., Nikolić, I., et al.[2014]

Electrical brain stimulation is an established and FDA-approved therapy for various conditions, including movement disorders and epilepsy, but there are still clinical gaps that newer systems could address.

Next-generation brain stimulation systems that integrate wearable sensors and off-the-body computing resources, like smartphones, could enhance treatment by allowing for real-time tracking of behavioral and physiological signals, leading to more adaptive and effective therapies for neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Brain Stimulation for Epilepsy and Emerging Applications. Worrell, GA.[2023]

This study presents the first case of safely administering electroconvulsive therapy (ECT) to a patient with deep brain stimulation (DBS) by temporarily interrupting DBS only during the ECT sessions.

Previous reports indicated no adverse events when DBS was withheld for the entire ECT course, but this case suggests that short interruptions during ECT may be a safe approach, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary interruption of deep brain stimulation for Parkinson's disease during outpatient electroconvulsive therapy for major depression: a novel treatment strategy. Ducharme, S., Flaherty, AW., Seiner, SJ., et al.[2011]

A review of 21 cases and a new case study at the University of Maryland Medical Center suggest that electroconvulsive therapy (ECT) can be safely administered to patients with implanted deep brain stimulators when proper precautions are taken.

No adverse events related to the deep brain stimulation device were reported in the literature, indicating that ECT does not pose a safety risk for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Electroconvulsive Therapy in Patients With Implanted Deep Brain Stimulators: A Review of the Literature and Case Report. Peroski, MS., Chu, MM., Doddi, SR., et al.[2020]

A retrospective analysis of 157 patients receiving 3,106 electroconvulsive therapy (ECT) applications showed a low incidence of serious and potentially life-threatening adverse events (pLTAEs) at just 0.097%, indicating that ECT is a relatively safe treatment when conducted in a controlled environment.

While minor adverse events were more common with higher stimulus doses and increased treatment frequency, no patients experienced permanent health damage or death, suggesting that ECT can be considered a viable option for treating depression in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Assessment of Electroconvulsive Therapy in Clinical Routine: A 3-Year Analysis of Life-Threatening Events in More Than 3,000 Treatment Sessions. Hajak, VL., Hajak, G., Ziegelmayer, C., et al.[2021]

In a study of 200 patients undergoing deep brain stimulation (DBS) procedures over a follow-up period of approximately 43 months, 20% experienced surgical or hardware-related adverse events (AEs), but all resolved without permanent effects.

The most common AEs were surgical site infections (9.95%) and wire tethering (2.49%), indicating that while AEs can occur, major complications requiring further surgery are rare, highlighting the overall safety of DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. Bouwens van der Vlis, TAM., van de Veerdonk, MMGH., Ackermans, L., et al.[2022]

Transcranial electrical stimulation (tES), including tDCS and MHF-tPCS, was found to be well tolerated in healthy subjects over a six-week period, with common side effects being mild skin sensations like tingling and itching, which were less frequent than in the sham-tDCS group.

The MHF-tPCS group showed significantly higher compliance in completing sessions compared to the sham-tDCS group, indicating that this waveform may be more acceptable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. Paneri, B., Adair, D., Thomas, C., et al.[2018]

Bilateral brain lesioning and deep brain stimulation (DBS) are being explored as potential treatments for severely ill psychiatric patients who do not respond to traditional therapies, with DBS offering the advantage of reversibility if side effects occur.

Preliminary results suggest that electrical stimulation may help with conditions like obsessive-compulsive disorder, but the exact mechanism of action and optimal stimulation targets are still unknown, indicating that further research is needed before it can be widely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the brain for psychiatric disorders. Nuttin, B., Gabriëls, L., Cosyns, P., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the treatment of severe, medically refractory obsessive-compulsive disorder. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in psychiatric disorders]. [2008]

4. Serbia pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in psychiatry. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Electrical Brain Stimulation for Epilepsy and Emerging Applications. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Temporary interruption of deep brain stimulation for Parkinson's disease during outpatient electroconvulsive therapy for major depression: a novel treatment strategy. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

The Safety of Electroconvulsive Therapy in Patients With Implanted Deep Brain Stimulators: A Review of the Literature and Case Report. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Assessment of Electroconvulsive Therapy in Clinical Routine: A 3-Year Analysis of Life-Threatening Events in More Than 3,000 Treatment Sessions. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the brain for psychiatric disorders. [2019]