Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease

NCT02908815 | Completed DMC

• 1 other identifier: B2016:077
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 0 and 5

Secondary Outcomes (10)

• Stroop Test

  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

• Digit Span Test

  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

• Verbal Fluency Test (VFT)

  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

• Neuropsychiatric Inventory-Questionnaire (NPI-Q)

  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

• Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

  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

Study Arms (4)

4 weeks active treatment

EXPERIMENTAL

4 weeks of rTMS active treatment applied using an active rTMS coil.

Device: rTMS active treatment

2 weeks active treatment

EXPERIMENTAL

2 weeks of rTMS active treatment applied using an active rTMS coil.

Device: rTMS active treatment

4 weeks sham treatment

SHAM COMPARATOR

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

Device: rTMS sham treatment

2 weeks sham treatment

SHAM COMPARATOR

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

Device: rTMS sham treatment

Interventions

rTMS active treatment DEVICE

Repetitive Transcranial Magnetic Stimulation uses magnetic pulses to active neurons.

2 weeks active treatment; 4 weeks active treatment

rTMS sham treatment DEVICE

A fake treatment designed to mimic the sensations of rTMS

2 weeks sham treatment; 4 weeks sham treatment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (3)

Monash University

Melbourne, Victoria, Australia

Location

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

Related Publications (3)

• Moussavi Z, Uehara M, Rutherford G, Lithgow B, Millikin C, Wang X, Saha C, Mansouri B, Omelan C, Fellows L, Fitzgerald PB, Koski L. Repetitive transcranial magnetic stimulation as a treatment for Alzheimer's disease: A randomized placebo-controlled double-blind clinical trial. Neurotherapeutics. 2024 Apr;21(3):e00331. doi: 10.1016/j.neurot.2024.e00331. Epub 2024 Feb 14.

  PMID: 38360452 DERIVED

• Moussavi Z, Koski L, Fitzgerald PB, Millikin C, Lithgow B, Jafari-Jozani M, Wang X. Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial. JMIR Res Protoc. 2021 Aug 9;10(8):e31183. doi: 10.2196/31183.

  PMID: 34383681 DERIVED

• Moussavi Z, Rutherford G, Lithgow B, Millikin C, Modirrousta M, Mansouri B, Wang X, Omelan C, Fellows L, Fitzgerald P, Koski L. Repeated Transcranial Magnetic Stimulation for Improving Cognition in Patients With Alzheimer Disease: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. JMIR Res Protoc. 2021 Jan 8;10(1):e25144. doi: 10.2196/25144.

  PMID: 33416500 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zahra Moussavi, PhD

  Department of Biomedical Engineering, University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 28, 2024

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2016-12-01 till 2021-12-30
• Access Criteria: Data are shared over a database that is only accessible by the sites of the study.

Locations

CA (2); AU (1)