Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ontario Shores Centre for Mental Health Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, open-label, observational study of the efficacy and safety of ECT for BPSD. There is no control or comparison group. Subjects will be compared on outcome measures pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects over three years
The study population are patients whom have a diagnosis of dementia and has behavioural and psychiatric symptoms of dementia (BPSD). In this study, the participants will have already been treated with antipsychotic medications as per usual practice but still do not have adequate symptoms control. One of the options in current clinical practice is to consider Electroconvulsive therapy (ECT) for treatment-resistant BPSD, particularly in those with psychosis and/or substantial aggression. Therefore, the study involves offering ECT to these individuals and measuring the patient's clinical status and severity of symptoms before and after ECT treatments by using standardized rating scales. Further, background information about the patient will be collected, such as their age and medical conditions.
ECT for BPSD has been done previously as reported in the medical literature. It has shown significant benefit for individuals when medication does not provide enough symptomatic relief. This research project is part of a larger multi-site study done in conjunction with Ontario Shores academic research group in Ontario, Canada. Active recruitment began in Ontario since October 2012, but our University of British Columbia (UBC) site is hoping to recruit further subjects to the total of 30 participants between the two sites.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropsychiatric Inventory (NPI) | The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked). The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144). NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course. | NPI measured 7 days pre-ECT and then 7 days after completing ECT course |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Agitation Scale (PAS) | The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care. Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect). The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0. PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion |
Not provided
Inclusion Criteria:
Severe BPSD: BPSD of sufficient severity that the safety of the patient or others precludes the possibility of discharge to any non-hospital environment.
Failed "standard of care for BPSD":
Non-pharmacological treatments (see Clinical Practice Guideline) are of insufficient benefit to allow discharge to any non-hospital environment, and
Pharmacological treatments are of insufficient benefit to allow discharge to any non-hospital environment. Pharmacological treatments must consist of the following prescribed specifically for BPSD:
Provided informed (substitute) consent to their attending psychiatrist for off-label treatment of BPSD with ECT as per the Health Care (Consent) and Care Facility (Admission) Act, and institutional policies and procedures.
Been medically-cleared for ECT by Anaesthesia as per the usual pre-ECT work-up for patients admitted to the Geriatric Psychiatry Units.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with dementia as defined by DSM-IV-TR criteria
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chan Peter | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Saint Joseph's Hospital | Vancouver | British Columbia | V5T3N4 | Canada | ||
| Vancouver General Hospital - Willow Pavilion |
Data will be collected and analyzed collectively and there is no plan of making the individual data available
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neuropsychiatric Inventory (NPI) | The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked). The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144). NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course. | Posted | Mean | Standard Deviation | units on a scale | NPI measured 7 days pre-ECT and then 7 days after completing ECT course |
|
Adverse effects are collected by using the Columbia ECT subjective side effect schedule. This 32 item scale will be administered at baseline (7 days pre-ECT) and in the afternoon following the 1st, 4th and 8th treatments and in the week following the course of ECT (post-treatment day 7).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient passed away 2 days after their last ECT due to pneumonia but it was felt that was unlikely to be directly related to ECT treatment as the patient was frail |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delirium | Renal and urinary disorders | Non-systematic Assessment | Two participants had ECT held temporarily due to increased confusion when they developed a urinary tract infection. The delirium in each was not deemed to be related to ECT. |
Retrospective design, medication use not controlled for.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Simon Woo | University of British Columbia | 604-520-4662 | simon.woo@fraserhealth.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2021 | Feb 5, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course |
| Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion | The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion | For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion |
| Change in Cornell-Brown Quality of Life Scale (CBS) | The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7) | For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion |
| Change in Functional Assessment Staging of Alzheimer's Disease (FAST) | The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way. The FAST scale has seven stages:
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined | For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| Ontario Shores | Whitby | Ontario | L1N 5S9 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Educational attainment | Count of Participants | Participants |
|
| Residential setting (i.e. community vs. institutional) | Count of Participants | Participants |
|
| Dementia type(s) | Count of Participants | Participants |
|
| Dementia severity (FAST scale described below) | The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the Mini Mental State Exam (MMSE) no longer can reflect changes in a meaningful clinical way. The FAST scale has seven stages:
| Mean | Standard Deviation | scores on scale |
|
| Previous ECT | Count of Participants | Participants |
|
| Study Participants |
Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist. |
|
|
| Secondary | Change in Pittsburgh Agitation Scale (PAS) | The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care. Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect). The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0. PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion | Some participants unfortunately did not have did available for analysis due to data not collected by research team staff | Posted | Mean | Standard Deviation | units on a scale | For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course |
|
|
|
| Secondary | Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion | The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion | Some participants unfortunately did not have did available for analysis due to data not collected by research team staff | Posted | Mean | Standard Deviation | units on a scale | For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion |
|
|
|
| Secondary | Change in Cornell-Brown Quality of Life Scale (CBS) | The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7) | Some participants unfortunately did not have did available for analysis due to data not collected by research team staff | Posted | Mean | Standard Deviation | units on a scale | For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion |
|
|
|
| Secondary | Change in Functional Assessment Staging of Alzheimer's Disease (FAST) | The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way. The FAST scale has seven stages:
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined | Posted | Mean | Standard Deviation | units on a scale | For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course |
|
|
|
| 1 |
| 33 |
| 1 |
| 33 |
| 5 |
| 33 |
|
|
| Agitation | Nervous system disorders | Non-systematic Assessment | Two participants manifested agitation/restlessness after ECT, and it was not clear if this represented an exacerbation of their (Neuro-Psychiatric Symptoms) NPS or if there was concurrent transient post-ECT delirium. |
|
| Hypotension/Bradycardia | Cardiac disorders | Non-systematic Assessment | One participant had a transient bout of hypotension and bradycardia after an ECT treatment |
|
Not provided
Not provided
| D001523 | Mental Disorders |