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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02908815




Registration number
NCT02908815
Ethics application status
Date submitted
13/09/2016
Date registered
21/09/2016
Date last updated
26/02/2021

Titles & IDs
Public title
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease
Scientific title
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease
Secondary ID [1] 0 0
B2016:077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - rTMS active treatment
Treatment: Devices - rTMS sham treatment

Experimental: 4 weeks active treatment - 4 weeks of rTMS active treatment applied using an active rTMS coil.

Experimental: 2 weeks active treatment - 2 weeks of rTMS active treatment applied using an active rTMS coil.

Sham Comparator: 4 weeks sham treatment - 4 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.

Sham Comparator: 2 weeks sham treatment - 2 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.


Treatment: Devices: rTMS active treatment
Repetitive Transcranial Magnetic Stimulation uses magnetic pulses to active neurons.

Treatment: Devices: rTMS sham treatment
A fake treatment designed to mimic the sensations of rTMS

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) change - Standard measure of cognitive symptoms, a popular tool that measures the severity of dementia symptoms. The primary outcome measure will be the change in the score from the baseline at 5 weeks.
Timepoint [1] 0 0
Weeks 0 and 5
Secondary outcome [1] 0 0
Stroop Test - Measures a person's attention by having them read colour names when the colour of the text doesn't match.
Timepoint [1] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [2] 0 0
Digit Span Test - Memory test asking the participant to remember a sequence of numbers and repeat them back.
Timepoint [2] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [3] 0 0
Verbal Fluency Test (VFT) - Fluency test where the participant has to name as many words a possible that match a certain criteria.
Timepoint [3] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [4] 0 0
Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver questionnaire that assesses severity of symptoms
Timepoint [4] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [5] 0 0
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) - Caregiver questionnaire that assesses patient's ability to handle daily activities
Timepoint [5] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [6] 0 0
Zarit Burden Interview (ZBI) - Caregiver questionnaire that assesses the burden of the patient on the caregiver
Timepoint [6] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [7] 0 0
Treatment Satisfaction Questionnaire for Medication (TSQM) - Assessment that asks directly if the participant is satisfied with the treatment
Timepoint [7] 0 0
Weeks 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [8] 0 0
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) effect over time - Standard measure of cognitive symptoms, a popular tool that measures the severity of dementia symptoms.
Timepoint [8] 0 0
Weeks 0, 3, 11, 19, and 27 for the 2 week group and weeks 0, 3, 13, 21, and 29 for the 4 week groups
Secondary outcome [9] 0 0
Semantic Fluency Test (SFT) - Fluency test where the participant has to name as many animals in 1 minute (Winnipeg and Montreal sites only)
Timepoint [9] 0 0
Before and immediately after rTMS intervention in Week 1, at weeks 5 and 11 for the 2 week group and before and immediately after rTMS intervention in Week 1, at weeks 5, and 13 for the 4 week groups
Secondary outcome [10] 0 0
Clinical Dementia Rating (CDR) sum of boxes - Assesses the severity of cognitive and functional decline related to Alzheimer's disease and other dementias
Timepoint [10] 0 0
Week 27 for the 2 week group and week 29 for the 4 week group

Eligibility
Key inclusion criteria
Inclusion criteria:

- Individuals must have a MoCA score between 7 and 25, indicating mild cognitive
impairment or dementia, a CDR score of 1-2, and a CSDD score of 18 or less.

- Participants must have probable early or moderate Alzheimer's disease as confirmed by
their treating neurologist, geriatrician, or psychiatrist, and/or by the study
doctors.

- Participants must be +55 years old.

- Participants must be taking a stable dose of an acetylcholinesterase inhibitor for at
least 3 months prior to study entry with no plans to change medication for the
duration of the study. Or if participants decide to stop taking their Alzheimer's
disease related medication, they must wait a minimum of 6 weeks prior to the start of
the intervention.
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Psychiatric conditions/disorders, or current neurological or medical disorders, other
than AD, that could interfere with the subjects' cooperative participation (e.g.
Severe agitation, prominent anxiety)

- Mental retardation

- Impaired visual and auditory acuity that confounds performance in cognitive tests

- Being diagnosed explicitly by other forms of dementia

- Confounding psychiatric disorders (e.g., schizophrenia, bipolar affective disorder) or
current neurological, systemic, or medical disorders (e.g., liver disease, congestive
heart failure, severe COPD) that may impair cognition and/or could affect attention
span.

- Use of benzodiazepines or other hypnotics during the study and preceding two weeks

- Use of drugs with anticholinergic properties

- Pharmacological immunosuppression

- Participation in a clinical trial with any investigational agent within two weeks
prior to study enrollment

- Current alcohol abuse

- History of epileptic seizures or epilepsy

- Contraindication for receiving TMS treatment according to a TMS questionnaire.

- Clinically significant abnormal laboratory findings which have not been approved by
the Principal Investigator.

- Inability to adequately communicate in English in Manitoba and Australia sites and
either English or French in Montreal site.

- Previous treatment with rTMS within the past 3 months

- A change in medication for AD, mood disorders, or pain during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of Manitoba
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this study is to investigate the effects of repetitive Transcranial
Magnetic Stimulation (rTMS) treatment on patients with probable early or moderate Alzheimer's
disease.
Trial website
https://clinicaltrials.gov/show/NCT02908815
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zahra Moussavi, PhD
Address 0 0
Department of Biomedical Engineering, University of Manitoba
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zahra Moussavi, PhD
Address 0 0
Country 0 0
Phone 0 0
204-474-7023
Fax 0 0
Email 0 0
Zahra.Moussavi@umanitoba.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02908815