Dementia
Conditions
Keywords
Electroconvulsive Therapy, Dementia
Brief summary
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
Detailed description
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.
Interventions
None listed
Sponsors
Ontario Shores Centre for Mental Health Sciences
University of British Columbia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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: * at least three atypical antipsychotic agents each for at least 4 weeks * at least one of the following for at least four weeks: an antidepressant, a cholinesterase inhibitor, and/or and N-methyl-D-aspartate (NMDA) receptor antagonist (i.e. memantine). * 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
* Patients that are medically unfit to undergo ECT as per consultation with an anesthetist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropsychiatric Inventory (NPI) | NPI measured 7 days pre-ECT and then 7 days after completing ECT course | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Agitation Scale (PAS) | For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course | 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 |
| Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion | For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course 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 |
| Change in Cornell-Brown Quality of Life Scale (CBS) | For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion | 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) |
| Change in Functional Assessment Staging of Alzheimer's Disease (FAST) | For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course | 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: 1. which is normal adult 2. which is normal older adult 3. which is early dementia 4. which is mild dementia 5. which is moderate dementia 6. which is moderately severe dementia 7. which is severe dementia FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Continuous | 74 years |
| Dementia severity (FAST scale described below) | 6.5 scores on scale STANDARD_DEVIATION 0.54 |
| Dementia type(s) Alzheimer's | 14 Participants |
| Dementia type(s) Frontotemporal | 5 Participants |
| Dementia type(s) Lewy Body | 1 Participants |
| Dementia type(s) Mixed | 3 Participants |
| Dementia type(s) Mixed Alzheimer and Vascular | 3 Participants |
| Dementia type(s) Others | 2 Participants |
| Dementia type(s) Parkinson's | 1 Participants |
| Dementia type(s) Vascular | 4 Participants |
| Educational attainment Below Highschool | 3 Participants |
| Educational attainment College | 1 Participants |
| Educational attainment Highschool | 11 Participants |
| Educational attainment University and above | 6 Participants |
| Educational attainment Unknown | 12 Participants |
| Previous ECT No | 30 Participants |
| Previous ECT Yes | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 22 Participants |
| Race/Ethnicity, Customized Sri Lankan | 1 Participants |
| Race/Ethnicity, Customized Unknown / No information | 9 Participants |
| Residential setting (i.e. community vs. institutional) Community | 2 Participants |
| Residential setting (i.e. community vs. institutional) Instiutional | 31 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 5 / 33 |
| serious Total, serious adverse events | 1 / 33 |
Outcome results
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.
Time frame: NPI measured 7 days pre-ECT and then 7 days after completing ECT course
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Change in Neuropsychiatric Inventory (NPI) | -32.79 units on a scale | Standard Deviation 24.72 |
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)
Time frame: For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion
Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Change in Cornell-Brown Quality of Life Scale (CBS) | 6.26 units on a scale | Standard Deviation 0.95 |
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
Time frame: For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion
Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion | -6.26 units on a scale | Standard Deviation 0.95 |
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: 1. which is normal adult 2. which is normal older adult 3. which is early dementia 4. which is mild dementia 5. which is moderate dementia 6. which is moderately severe dementia 7. which is severe dementia FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined
Time frame: For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Change in Functional Assessment Staging of Alzheimer's Disease (FAST) | 0.12 units on a scale | Standard Deviation 0.6 |
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
Time frame: For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course
Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Change in Pittsburgh Agitation Scale (PAS) | -4.83 units on a scale | Standard Deviation 1.14 |