NCT01894620

Brief Summary

This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a technique that stimulates the brain by rapidly switching a magnetic field in a coil placed over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain region that we are interested in.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2018

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

July 3, 2013

Results QC Date

January 6, 2016

Last Update Submit

February 22, 2021

Conditions

Alzheimer's Disease

Keywords

Alzheimer'srTMSsleep qualitydementiamemory

Outcome Measures

Primary Outcomes (1)

  • Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)

    We anticipate to see a cognitive improvement as measured by the Montreal Cognitive Assessment (MoCA) after two weeks of applying rTMS. This assessment tool gives a score from 0 to 30 points, with higher scores representing better cognitive ability.

    Change between baseline and 2 weeks after the start of treatment

Secondary Outcomes (1)

  • Improvement in Sleep Quality

    After four weeks after the start of treatment

Study Arms (2)

rTMS with sham coil

PLACEBO COMPARATOR

rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.

Device: rTMS real-shamDevice: rTMS sham-real

rTMS with real coil

ACTIVE COMPARATOR

rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.

Device: rTMS real-shamDevice: rTMS sham-real

Interventions

rTMS real-shamDEVICE

In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.

rTMS with real coilrTMS with sham coil
rTMS sham-realDEVICE

In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment.

rTMS with real coilrTMS with sham coil

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals must have a MoCA score between 5 and 26, indicating mild cognitive impairment or dementia.
  • Participants must have probable early or moderate Alzheimer's disease as confirmed by their treating neurologist or psychiatrist, and/or by the co-investigators.

You may not qualify if:

  • A recent (the last 3 months) history of stroke, recent (the last 3 months) head injury and loss of consciousness, any history of epilepsy, seizures, multiple sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), or Autism.
  • Recent changes in medication (i.e. patients should be in a relatively stable phase of disease).
  • The presence of metallic objects in the body; dental implants are fine but people with pacemakers are to be excluded; basically anything that is unsafe under MRI would be considered unsafe for TMS application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misericordia Health Center

Winnipeg, Manitoba, R3C 1A2, Canada

Location

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Location

MeSH Terms

Conditions

Alzheimer DiseaseSleep Initiation and Maintenance DisordersDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Results Point of Contact

Title
Dr Zahra Moussavi
Organization
University of Manitoba
Zahra.Moussavi@umanitoba.ca
204 474-7023

Study Officials

  • Zahra Kazem-Moussavi, Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

February 24, 2021

Results First Posted

February 12, 2018

Record last verified: 2021-02

Locations

CA(2)