Treatment Resistant Depression Clinical Trial
Official title:
Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (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 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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 90 Years |
Eligibility | Inclusion Criteria: - Diagnosis of major depressive disorder using mini-7 to derive RDC; DSM-IV - Pretreatment HRSD score greater than or equal to 18 - ECT indicated by physician evaluation - Willing and capable of providing informed consent as determined by physician evaluation Exclusion Criteria: - History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by mini-7; rapid cycling defined as greater than or equal to four episodes in past year - History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history - Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation - Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation - Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation - ECT in the past six months determined by physician evaluation and medical history - Pregnancy as determined by urine pregnancy test and clinical interview |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seizure Drive Markers on EEG | Electrophysiological markers of the induced seizure will be captured with a 6-lead EEG placed over bilateral frontal, temporal and parietal lobes. Raw data will be collected in MicroVolts while the analysis will summarize connectivity measures. Right prefrontal activity and seizure drive will be contrasted to other regions from which EEG is recorded, to describe the focality of FEAST-induced seizures. | 8 weeks | |
Primary | Seizure characteristics on EEG | Length of induced seizures is measured by EEG and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed. | 8 weeks | |
Primary | Seizure characteristics by motor observation | Length of induced seizures is measured by motor observation and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed. | 8 weeks | |
Secondary | Change in Hamilton Depression Rating Score (HDRS) | Change in HDRS from baseline to completion of each ECT treatment compared between 2 treatments - FEAST or FEAST RP. HDRS is a 24-item interview-based tool measuring depression symptoms in the previous week. Scoring is based on only the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores are the sum of the 17 item scores and range from 0 (Normal functioning) to 22 (severe depression). | 8 weeks | |
Secondary | Change in Inventory for Depressive Symptoms - Self Report (IDS-SR) Score | Change in IDS-SR scores from baseline to completion of each ECT treatment compared between 2 treatments - FEAST or FEAST RP. IDS-SR is a 30-item self report tool measuring depression symptoms in the previous week. Items are scored from 1 (normal functioning) to 3 (severely impaired) with some items scored on a yes (score of 1) or no (score of zero) basis. Items are summed to calculate the total score, which ranges from 0 (normal functioning) to 84 (severely impaired). | 8 weeks | |
Secondary | Time to Reorientation | Time between subject open eyes immediately after procedure and correctly identifying 4 out of 5 questions on orientation to name, time and space will be noted in seconds. | 8 weeks | |
Secondary | Amnestic Side Effects | Amnestic side effects will be determined via cognitive assessment and compared pre- and post-FEAST treatment. | 8 weeks |
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