Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia
- Conditions
- AgitationAggressionDementia
- Interventions
- Other: Standard Care (Non-ECT group)Other: ECT treatment
- Registration Number
- NCT01856010
- Lead Sponsor
- Pine Rest Christian Mental Health Services
- Brief Summary
Agitation/aggression is one of the most common and serious behavioral complications of dementia. If the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. Retrospective reviews and preliminary studies have indicated Electroconvulsive Therapy (ECT) may be a safe, effective intervention in this patient population. This study will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ECT who accept this intervention vs. those patients referred for ECT but decline this intervention (i.e. standard care controls). It will also assess adverse events, activities of daily living and caregiver burden during study participation. The hypothesis is that subjects with dementia related aggression/agitation who receive ECT will show significantly greater reductions in these behaviors than subjects who do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our knowledge, this is the first prospective study to examine whether patients receiving ECT or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Patients age 50 years or older from the Older Adult Unit of Pine Rest Christian Mental Health Services or Geriatric Unit at McLean Hospital
- Diagnosis of Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Criteria
- Mini Mental Status Examination (MMSE) score of 16 or greater
- Fluent in English
- Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score of 4 or greater on at least one aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occuring in frequency of 2 and 1 at frequency of 3.
- A therapeutic decision will have already been made by the treating psychiatrist in consultation with the ECT team to use ECT treatment for agitation and aggression associated with dementia, with or without depression/mania. Patients will be included in the ECT treatment group if their legal representative consents to ECT treatment. Patients whose legal representative does not consent to ECT treatment will be included in the Standard Care (Non-ECT) treatment group.
- Informed Consent signed by authorized legal guardian and assent given by the participant
- Signed Authorization for Release of Healthcare Information by authorized legal guardian
- Current diagnosis of co-morbid delirium according to DSM-IV upon study entry
- ECT treatment within 90 days prior to study enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard Care (Non-ECT Group) Standard Care (Non-ECT group) Those who were referred for ECT treatment for behavior refractory to standard care, but who opted to not undergo ECT treatment and continue with standard care. ECT Treatment ECT treatment Those who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment
- Primary Outcome Measures
Name Time Method Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures agitation or aggression outcomes - completed by primary caregiver
- Secondary Outcome Measures
Name Time Method Severe Impairment Battery (SIB) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Gathers direct performance-based data from the subject with dementia on a wide variety of low-level tasks that take into account the specific behavioral and cognitive deficits associated with severe dementia
Neuropsychiatric Inventory Nursing Home Version (NPI) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures neuropsychiatric symptoms outcomes and caregiver burden - completed by primary caregiver
Clinical Global Impression Scale: Severity (CGI-S) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Indicates severity of dementia with agitation/aggression at the time of assessment - completed by physician
Mini Mental Status Examination (MMSE) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures cognition - primary caregiver completes with subject
Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures concentration, attention and memory - primary caregiver completes with subject
Cornell Scale for Depression in Dementia (CSDD) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Assesses the presence and severity of depressive symptoms - completed by primary caregiver
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures functional ability outcomes - completed by primary caregiver
Use of Psychoactive "As Needed" (PRN) Medication Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Records use of PRN medication for agitation/aggression
Geriatric Evaluation of Mental Status (GEMS) Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Measures list learning tasks to assess verbal memory outcome - primary caregiver completes with subject
Delirium and/or adverse reactions to ECT or medication Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks Assessed by treating physician
Trial Locations
- Locations (2)
Older Adult Unit of Pine Rest Christian Mental Health Services
🇺🇸Grand Rapids, Michigan, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States