Clinical trial NCT01894620: The Effect of rTMS Treatment on Alzheimer's and Sleep Quality
Official title: Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
rTMS
sleep quality
dementia
memory
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the TMS Lab at Riverview Health Center. Each treatment session will involve implementing rTMS, while the patient is involved in a cognitive exercise such as naming object or action. The study sessions will be scheduled as follows: Block 1: 5 days/week for two weeks followed by 2 days a week for 1 week, followed by once a week for 1 week (total of 13 treatments); Pause: 4 weeks of no treatment; and Block 2: another 13 sessions of treatment with the same pattern as Block 1. One of these two sets of treatment (Block 1 or Block 2) will be sham and one will be real. Sham treatment sessions are identical to real treatment sessions, except that there is no magnetic stimulation. Patients will be randomly assigned to receive either sham or real treatment first. The purpose of sham treatment is to have a control group data that the plausible improvement as a result of rTMS can be compared to. By designing two sets of sham-real or real-sham treatment sessions, every participant will receive a real treatment, while we will also have control data.

The cognitive assessments will be done at the baseline, and then on weekly basis. A subgroup of the study population will be recruited for investigating the second objective: effect of rTMS on sleep quality. Those patients will be required to sign a second consent; then, the patients will go through full-night sleep study at Misericordia Health Center at the same time intervals as their cognitive assessments.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)
timeFrame: Change between baseline and 2 weeks after the start of treatment
Secondary outcomes:
measure: Improvement in Sleep Quality
timeFrame: After four weeks after the start of treatment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Misericordia Health Center
state: Manitoba
city: Winnipeg
country: Canada
facility: Riverview Health Center
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Zahra Kazem-Moussavi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: