Enhanced ECT for Depression

Overseen By Rachel Johnson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Schizophrenia, Neurological illness, Substance abuse, 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: 29

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of Electroconvulsive Therapy (ECT) designed to reduce memory loss while alleviating depression symptoms. By adjusting electrode placement on the head, the trial aims to better target the brain's Prefrontal Cortex, believed to aid in treating depression. Two experimental methods are under evaluation: one employs a specific electrode setup known as Focal Electrically-Administered Seizure Therapy (FEAST), and the other uses a reversed current flow (RP FEAST) to determine which is more effective. Individuals with major depressive disorder who have been recommended ECT by a doctor may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance ECT for future patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your physician for guidance.

What prior data suggests that this method is safe for treating depression?

Research has shown that Focal Electrically-Administered Seizure Therapy (FEAST) is generally safe for people with depression. Studies indicate that it can improve depression symptoms with fewer memory issues compared to traditional Electroconvulsive Therapy (ECT). One study found that FEAST led to significant improvements in depression and allowed patients to return to their normal mental state relatively quickly.

For the version called RP FEAST, early data suggest it might target the brain more precisely. This precision could enhance effectiveness or further reduce side effects. Both options are part of ongoing research to make ECT safer and more effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced Spatial Targeting in ECT utilizing FEAST for depression because it offers a more focused approach to Electroconvulsive Therapy (ECT). Unlike standard ECT, which often uses a broad, generalized electrical stimulation, FEAST employs unidirectional stimulation and asymmetrical electrode configurations to target specific brain areas more precisely. Additionally, the experimental treatment arm, RP FEAST, introduces a reversed polarity of current flow, potentially enhancing the therapy's effectiveness. These advancements could lead to more efficient treatments with fewer side effects, offering hope for those who haven't found relief with traditional ECT or other depression therapies.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that FEAST, a new type of Electroconvulsive Therapy (ECT), may help treat depression with fewer side effects. Studies indicate that FEAST offers similar benefits to traditional ECT but with less memory loss. This trial will compare two methods: FEAST, which uses a special technique to direct the electrical current more precisely, and RP FEAST, which may allow for quick recovery with focused seizure activity. Both FEAST and RP FEAST aim to improve depression symptoms while reducing the mental side effects often linked to standard ECT treatments. ^{1 2 4 6 7}

Who Is on the Research Team?

Ziad Nahas, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with major depressive disorder who have a significant level of depression and are deemed suitable for ECT by their doctor. They must be able to consent to treatment. Excluded are those with recent substance abuse, certain psychiatric or neurological conditions, pregnancy, or recent ECT.

Inclusion Criteria

I have been diagnosed with major depression.

Pretreatment HRSC score greater than or equal to 18

My doctor has recommended electroconvulsive therapy.

Exclusion Criteria

I have not had electroconvulsive therapy in the last 6 months.

Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation

I do not have a diagnosis of delirium, dementia, amnesia, epilepsy, and I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments for cognition, mood, and quality of life, including a baseline MRI

1 week

1 visit (in-person)

Treatment

Participants receive FEAST or RP FEAST treatments 3 times per week, with dose adjustments based on response

8 weeks

24 visits (in-person)

Follow-up

Follow-up assessments of cognition, mood, and quality of life after the 6th, 12th, and 15th treatments

2 weeks

3 visits (in-person)

Optional MRI Follow-up

Optional follow-up MRI to assess changes post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Spatial Targeting in ECT Utilizing FEAST

Trial Overview The study tests FEAST, an alternative form of ECT aimed at reducing memory loss by targeting the Prefrontal Cortex more precisely using adjusted electrodes on one side of the head. The procedure includes anesthesia and recovery monitoring similar to standard ECT.

How Is the Trial Designed?

Group I: B: RP FEAST Experimental Treatment 2 Interventions

Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Polarity (RP) utilizes the same electrode placement as FEAST but a reversed directionality of current flow.

Group II: A: FEAST Experimental Treatment 2 Interventions

Focally Electrically-administered Seizure Therapy (FEAST) is a form of Electroconvulsive therapy (ECT) that combines unidirectional stimulation, control of polarity, and an asymmetrical electrode configuration.

Enhanced Spatial Targeting in ECT Utilizing FEAST is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electroconvulsive Therapy for:

• Major Depressive Disorder
• Severe Mental Health Conditions
• Schizophrenia

Approved in European Union as Electroconvulsive Therapy for:

• Major Depressive Disorder
• Severe Mental Health Conditions
• Schizophrenia

Approved in Canada as Electroconvulsive Therapy for:

• Major Depressive Disorder
• Severe Mental Health Conditions
• Schizophrenia

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A novel form of electroconvulsive therapy (ECT) called focal electrically administered seizure therapy (FEAST) demonstrated lower seizure thresholds compared to traditional bilateral ECT, suggesting it may enhance the efficacy of treatment for severe depression.

The study found that unidirectional stimulation and specific electrode configurations significantly influence seizure induction efficiency, which could lead to improved ECT protocols and potentially reduce cognitive side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal electrically administered seizure therapy: a novel form of ECT illustrates the roles of current directionality, polarity, and electrode configuration in seizure induction. Spellman, T., Peterchev, AV., Lisanby, SH.[2021]

Focal Electrically-Administered Seizure Therapy (FEAST) shows similar efficacy to Right Unilateral Ultrabrief Pulse ECT (RUL-UBP) in treating depression, with a response rate of 65% for FEAST compared to 57.9% for RUL-UBP.

FEAST may lead to milder cognitive side effects, as indicated by a shorter average time to reorientation and better memory consistency scores, although these findings did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT). Sahlem, GL., McCall, WV., Short, EB., et al.[2023]

Focal electrically-administered seizure therapy (FEAST) successfully triggered focal seizures in the right prefrontal cortex of a 72-year-old man, showing early increases in regional cerebral blood flow (rCBF) in that area.

Post-ictally, FEAST resulted in reduced blood flow in the frontal and occipital cortices while increasing flow in the left motor and precuneus cortex, indicating a complex pattern of brain activity following the seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional cerebral blood flow changes associated with focal electrically administered seizure therapy (FEAST). Chahine, G., Short, B., Spicer, K., et al.[2018]

In a study involving 17 unmedicated adults with severe depression, Focal Electrically Administered Seizure Therapy (FEAST) showed a significant improvement in depression scores, with a 46.1% reduction in Hamilton Rating Scale for Depression (HRSD24) scores after a median of 10 sessions.

FEAST demonstrated a relatively quick recovery time for cognitive function, with patients achieving full reorientation in about 5.5 minutes after treatment, suggesting it may have fewer cognitive side effects compared to traditional electroconvulsive therapy (ECT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST]. Nahas, Z., Short, B., Burns, C., et al.[2016]

Focal electrically administered seizure therapy (FEAST) demonstrated a significant improvement in depression scores, with 65% of participants showing a response and 55% achieving remission after an average of 9.3 treatment sessions.

FEAST was well-tolerated with no dropouts, and patients experienced quick reorientation after treatment, averaging 4.4 minutes, while showing no decline in cognitive function, suggesting it may be a safer alternative to conventional electroconvulsive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Safety and Efficacy Data for a New Method of Performing Electroconvulsive Therapy: Focal Electrically Administered Seizure Therapy. Sahlem, GL., Short, EB., Kerns, S., et al.[2018]

Focal electrically administered seizure therapy (FEAST) demonstrated comparable reductions in suicidal ideation to ultrabrief pulse, right unilateral electroconvulsive therapy (UB-RUL ECT) in a study of 39 patients with major depressive episodes.

Both treatment methods significantly lowered scores on the Beck Scale for Suicide Ideation and the Hamilton Rating Scale for Depression, suggesting that FEAST may be a viable alternative to traditional ECT with potentially fewer cognitive side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Focal Electrically Administered Seizure Therapy Compared With Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy on Suicidal Ideation: A 2-Site Clinical Trial. Youssef, NA., George, MS., McCall, WV., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04099342

Enhanced Spatial Targeting in ECT Utilizing FEAST The purpose of this research study is to find an alternative version of ECT that reduces the negative side effects (mainly memory loss) while still ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4226514/

Focal Electrically Administered Seizure Therapy (FEAST) These findings suggest that current directionality, polarity, and electrode configuration influence the efficiency of seizure induction with ECT.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23518262/

focal electrically administered seizure therapy [FEAST] In this feasibility study, FEAST produced clinically meaningful antidepressant improvement, with relatively short time to reorientation.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X20302138

A two-site, open-label, non-randomized trial comparing ... FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02462551?tab=table

Focal Electrically Administered Seizure Therapy for the ... Electroconvulsive therapy (ECT) remains the most effective acute antidepressant treatment for TRD, but with significant risks of cognitive impairment. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8606010/

The Effects of Focal Electrically-Administered Seizure ... Preliminary data suggest that Focal Electrically-Administered Seizure Therapy (FEAST) has antidepressant effects and less adverse cognitive effects than ...

7. scholars.duke.edu scholars.duke.edu/individual/pub1630259

Focal Electrically Administered Seizure Therapy. We recently reported on the safety and feasibility of FEAST in a cohort (n = 17) of depressed patients. We now report on the safety, feasibility, preliminary ...