Amplitude Titration to Improve ECT Clinical Outcomes Randomized Clinical Trial
University of New Mexico
Summary
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT: H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2). H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Description
ECT dosing can be divided into three categories for the ECT responder: insufficient (no antidepressant response, no cognitive impairment), optimal (antidepressant response, no cognitive impairment), or excessive (antidepressant response, cognitive impairment). Traditional fixed amplitude ECT dosing with 800 mA adjusts pulse train duration and frequency based on seizure titration or demographic factors (age, sex). Fixed amplitude produces variable electric fields and ECT dosing secondary to individual neuroanatomic differences. Adjustments to pulse width, pulse train duration, and frequency do…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of major depressive disorder or bipolar II * Clinical indications for ECT with right unilateral electrode placement Exclusion Criteria: * 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) * Contraindications to MRI.
Interventions
- DeviceSoterix Medical Incorporated 4x1 adapter
Device permits individualized amplitudes
- DeviceTraditional ECT device
FDA approved ECT device with fixed amplitude.
Location
- University of New Mexico Health Science CenterAlbuquerque, New Mexico