Long-term Potentiation Disruption Underlying Cognitive Impairment in ECT

NCT06733558 | Withdrawn Early Phase 1

• 2 other identifiers: 23-2865P20GM109089-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive problems, like memory loss, are common after brain injuries like trauma or stroke. These problems make daily life harder, and the investigators don't yet know the best ways to help the brain recover. Scientists think that a process in the brain called long-term potentiation (LTP) is important for memory and learning. When LTP isn't working properly, it may cause problems with thinking and memory. But studying LTP in people is hard because it happens deep inside the brain. Our research uses a treatment called electroconvulsive therapy (ECT) to better understand LTP. ECT is a treatment for severe depression that works by causing a controlled seizure in the brain. While ECT often helps depression, it can temporarily cause memory and thinking problems, which usually improve over time. This makes ECT a good way to study how thinking and memory recover. The investigators will use a tool called electroencephalography (EEG) to measure brain activity during different stages of ECT treatment. EEG is a safe and non-invasive way to track changes in LTP. Specifically, the investigators will measure how the brain responds to visual signals using something called visual evoked potentials (VEPs). These signals can show how LTP is affected by ECT. The study's main goal is to track changes in LTP using VEPs during and after ECT. By studying these changes, the investigators hope to learn how ECT affects the brain and how it recovers. This could help improve treatments for brain injuries and other conditions that cause memory and thinking problems.

Conditions

Major Depressive Disorder; Bipolar Disorder II

Keywords

electroconvulsive therapy; brain recovery; major depressive disorder; long-term potentiation; cognitive impairment; bipolar disorder, type II

Outcome Measures

Primary Outcomes (1)

• Visual Evoked Potential

  The primary outcome of this study is to measure changes in long-term potentiation (LTP)-like phenomena using visual evoked potentials (VEPs), a non-invasive marker of brain activity recorded through electroencephalography (EEG). VEPs are brain responses to visual stimuli, and the N1 component, a negative peak occurring approximately 100 milliseconds after the stimulus, serves as a reliable index of LTP-like phenomena in humans. In this study, participants will undergo a visual stimulation paradigm designed to elicit and measure changes in the amplitude of the N1 component. This approach allows us to assess changes in synaptic plasticity (a key feature of LTP) before, during, and after a series of electroconvulsive therapy (ECT) treatments. These measurements will be correlated with cognitive performance and memory changes to explore the relationship between ECT-induced cognitive effects and LTP disruption.

  From enrollment to eight weeks after enrollment

Study Arms (1)

Participants undergoing ECT

EXPERIMENTAL

Participants undergoing ECT for depressive episode

Procedure: Electroconvulsive Therapy

Interventions

Electroconvulsive Therapy PROCEDURE

Electroconvulsive therapy (ECT) is a medical treatment that uses controlled electrical stimulation to induce a brief, generalized seizure in the brain. This intervention is performed under general anesthesia with muscle relaxants to ensure patient comfort and safety. ECT is typically used to treat severe depression, bipolar disorder, and other mental health conditions when other treatments, such as medication and psychotherapy, have not been effective.

Participants undergoing ECT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of major depressive disorder (MDD; with or without psychotic features) or bipolar 2 most recent episode depressed;
• clinical indications for ECT with right unilateral electrode placement including treatment resistance or a need for a rapid and definitive response,
• age range adults 18-85 years, and
• English-speaking (many of the neuropsychological tests are only available in English). Antidepressant medications will be continued as clinically indicated. To maintain feasibility and retention, as needed medications will be permitted for anxiety and insomnia.

You may not qualify if:

• Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease);
• other psychiatric conditions (e.g., schizophrenia, bipolar I disorder);
• current drug or alcohol use disorder (except for nicotine);
• prisoners; and
• pregnancy (pre- menopausal participants will receive pregnancy test, which is clinically indicated for ECT and not part of study protocol).

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• University of New Mexico: lead

Study Sites (1)

Domenici Hall

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Cognitive Dysfunction

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Masking will not be necessary, as there is only one group.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be only one group that will be studied, those undergoing ECT.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)