Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss

NCT06445894 | Not Yet Recruiting

• 1 other identifier: 17300
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The process of aging is accompanied by normal deterioration of body systems, leading to a decline in various functional domains including cognitive, visual, vestibular, somatosensory, and motor function. With this functional decline, there is an increasing burden of care due to the rise of injury, direct and indirect healthcare costs, and the loss of independence in performing daily activities. Notably, falls in the older population represents one of the greatest costs incurred by Canadians annually. The study investigates whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC. Determining this answer will allow greater success in TMS target refinement. Given the profound burden that geriatric medicine has on the Canadian healthcare system, understanding the link between balance and cognition can significantly impact the approach to management of this population.

Conditions

Dementia Alzheimers

Keywords

neuroplasticity; transcranial magnetic stimulation; dementia

Outcome Measures

Primary Outcomes (1)

• Time Up & Go (TUG) task

  Patients wear their regular footwear and can use a walking aid, if needed. It will begin by having the patient sit back in a standard armchair and identify a line 3 meters, or 10 feet away, on the floor. The participant will be instructed "When I say "Go," I want you to: 1. Stand up from the chair. 2. Walk to the line on the floor at your normal pace. 3. Turn. 4. Walk back to the chair at your normal pace. 5. Sit down again." During this task, IMU will be worn on the ankle to collect movement kinematics relating to balance. During this task two research personnel, one positioned on either side of the participant, will be present in order to stabilize the participant in the case of a loss of balance. In addition, foam padding will be positioned surrounding the patient during standing assessments and moved alongside the patient in walking assessments

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

Secondary Outcomes (8)

• Activities-Specified Balance Confidence (ABC) scale

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

• Mini-Balance Evaluation Systems Test (M-BESTest)

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

• Balance Assessment test

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

• Geriatric Anxiety Inventory (GAI)

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

• Cornell Scale for Depression in Dementia (CSDD)

  At baseline 1-2 days pre-intervention, and 1-2 days post-intervention

Study Arms (3)

Active rTMS to M1

ACTIVE COMPARATOR

iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere . Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).

Device: Active Repetitive Transcranial Magnetic Stimulation

Active rTMS to DLPFC

ACTIVE COMPARATOR

iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target DLPFC. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered \[13,22\]. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere \[13,23,27\]. Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).

Device: Active Repetitive Transcranial Magnetic Stimulation

Placebo rTMS to M1

PLACEBO COMPARATOR

sham iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of placebo stimulation. Following sham iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Active Repetitive Transcranial Magnetic Stimulation DEVICE

rTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The first dorsal interossesous (FDI) muscle of the left motor cortex will be targeted using neuronavigation software.

Active rTMS to DLPFC; Active rTMS to M1

Sham Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

A sham coil will be utilized for the sham rTMS condition. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active. The location and all other parameters of Sham rTMS will be identical to Active rTMS.

Placebo rTMS to M1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be diagnosed with Dementia and/or memory loss by a clinician.
• Individuals must exhibit adequate oral communication skills and cognitive function sufficient to obtain a score ranging between 10-27 on the Mini-Mental State Exam (Wu et al., 2022).
• Instructions will be delivered in English; therefore participants must demonstrate an understanding of instruction provided in English or have a caregiver present who can translate and be presented during all study sessions.
• Individuals must be able to walk or stand with or without personnel or assistive devices.
• Individuals must be greater than or equal to 50 years of age.

You may not qualify if:

• \. Contraindications to rTMS; presence of a pacemaker, metal/electrical/magnetic implants not including titanium, known history of untreated or uncontrolled psychological disorders, pregnancy, history of seizure or diagnoses of epilepsy, are taking any prescription medications that increase the risk of seizure.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Unviersity

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aimee J Nelson, PhD

CONTACT

9055259140; nelsonaj@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

CA (1)