20 Participants Needed

Enhanced ECT for Depression

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Overseen ByRachel Johnson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the idea that Enhanced ECT for Depression is an effective treatment?

The available research shows that Enhanced ECT, specifically Focal Electrically Administered Seizure Therapy (FEAST), is effective for treating depression. Studies indicate that FEAST has antidepressant effects and causes fewer cognitive side effects compared to traditional ECT. For example, one study found that FEAST had less impact on cognitive functions while still being effective in reducing symptoms of depression. Additionally, FEAST was compared to another form of ECT, Right Unilateral Ultrabrief Pulse ECT, and was found to have similar antidepressant effects but with reduced cognitive side effects. This suggests that FEAST is a promising treatment option for depression with potentially fewer negative impacts on memory and thinking.12345

What safety data is available for Enhanced ECT for Depression?

The safety data for Enhanced ECT, specifically Focal Electrically-Administered Seizure Therapy (FEAST), indicates that it may have reduced cognitive side effects compared to traditional ECT. Multiple studies have explored its safety, feasibility, and cognitive effects. Initial trials suggest that FEAST is safe and feasible, with potentially fewer cognitive adverse effects than traditional ECT methods. However, these findings are based on preliminary data and further research is needed to confirm these results.13456

Is Enhanced Spatial Targeting in ECT (FEAST) a promising treatment for depression?

Yes, Enhanced Spatial Targeting in ECT (FEAST) is a promising treatment for depression. It aims to reduce cognitive side effects compared to traditional ECT by focusing the electrical stimulus more precisely. Studies suggest it has antidepressant effects and may be safer for the brain.12345

What is the purpose of this trial?

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 providing patients with relief from depressive symptoms. Previous forms of ECT may use Bilateral (electrodes on both sides of the head) or Right Unilateral (RUL) (electrodes on one side of the head). Our research focuses on adjusting the placement of electrodes on one side of the head in order to better stimulate the Prefrontal Cortex (PFC) of the brain. By more specifically targeting the PFC, it is predicted that participants will receive the same benefit as ECT but will have fewer negative side effects after the treatment, mainly less memory loss. All other aspects of the treatment will be similar to regular, clinical ECT, including anesthesia and recovery monitoring. To accomplish this stimulation, an adjusted MECTA Spectrum 5000Q device will be used. If successful, this research study will demonstrate a way to improve ECT procedures for all patients suffering from Major Depressive Disorder by minimizing side effects and maintaining or improving efficacy.

Research Team

Ziad Nahas | Medical School

Ziad Nahas, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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.
See 1 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: B: RP FEASTExperimental Treatment2 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: FEASTExperimental Treatment2 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:

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Approved in United States as Electroconvulsive Therapy for:
  • Major Depressive Disorder
  • Severe Mental Health Conditions
  • Schizophrenia
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Approved in European Union as Electroconvulsive Therapy for:
  • Major Depressive Disorder
  • Severe Mental Health Conditions
  • Schizophrenia
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Electroconvulsive Therapy for:
  • Major Depressive Disorder
  • Severe Mental Health Conditions
  • Schizophrenia

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

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).
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]
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.
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.
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]

References

A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST]. [2016]
Focal electrically administered seizure therapy: a novel form of ECT illustrates the roles of current directionality, polarity, and electrode configuration in seizure induction. [2021]
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). [2023]
Expanded Safety and Efficacy Data for a New Method of Performing Electroconvulsive Therapy: Focal Electrically Administered Seizure Therapy. [2018]
The Effects of Focal Electrically Administered Seizure Therapy Compared With Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy on Suicidal Ideation: A 2-Site Clinical Trial. [2023]
Regional cerebral blood flow changes associated with focal electrically administered seizure therapy (FEAST). [2018]
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