Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECT Treatment | Those who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECT treatment | Other | The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide to do ECT treatment, they are in the ECT group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI) | Measures agitation or aggression outcomes - completed by primary caregiver | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Impairment Battery (SIB) | 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 | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Individuals age 50 or older that have been diagnosed with dementia and associated agitation and aggression and have already been referred for ECT.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jack Mahdasian, MD | Pine Rest Christian Mental Health Services | Principal Investigator |
| Brent P Forester, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States | ||
| Older Adult Unit of Pine Rest Christian Mental Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22143072 | Result | Ujkaj M, Davidoff DA, Seiner SJ, Ellison JM, Harper DG, Forester BP. Safety and efficacy of electroconvulsive therapy for the treatment of agitation and aggression in patients with dementia. Am J Geriatr Psychiatry. 2012 Jan;20(1):61-72. doi: 10.1097/JGP.0b013e3182051bbc. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000374 | Aggression |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Care (Non-ECT group) | Other | The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide not to do ECT treatment and continue with standard care, they are in the Standard Care (Non-ECT) Group. |
|
| Cornell Scale for Depression in Dementia (CSDD) | Assesses the presence and severity of depressive symptoms - completed by primary caregiver | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Neuropsychiatric Inventory Nursing Home Version (NPI) | Measures neuropsychiatric symptoms outcomes and caregiver burden - completed by primary caregiver | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Clinical Global Impression Scale: Severity (CGI-S) | Indicates severity of dementia with agitation/aggression at the time of assessment - completed by physician | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Mini Mental Status Examination (MMSE) | Measures cognition - primary caregiver completes with subject | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards) | Measures concentration, attention and memory - primary caregiver completes with subject | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Geriatric Evaluation of Mental Status (GEMS) | Measures list learning tasks to assess verbal memory outcome - primary caregiver completes with subject | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) | Measures functional ability outcomes - completed by primary caregiver | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Use of Psychoactive "As Needed" (PRN) Medication | Records use of PRN medication for agitation/aggression | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Delirium and/or adverse reactions to ECT or medication | Assessed by treating physician | Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks |
| Grand Rapids |
| Michigan |
| 49548 |
| United States |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |