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Completed

NCT Number: NCT01894620

The Effect of rTMS Treatment on Alzheimer's and Sleep Quality

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misericordia Health Center, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS real-sham

Device

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 sham-real

Device

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.

Primary outcomes

  1. Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)

    Time frame: Change between baseline and 2 weeks after the start of treatment

    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.

Secondary outcomes

  1. Improvement in Sleep Quality

    Time frame: After four weeks after the start of treatment

    We anticipate to see an improvement on the sleep quality of the patients (assessed by EEG waves during sleep) after 4 weeks of rTMS treatment.

Sponsors and collaborators

Lead sponsor

Dr. Zahra Kazem-Moussavi

Other

Registry information

Official study title

Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality

Acronym: rTMS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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