Dementia Alzheimers Clinical Trial
Official title:
Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss
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.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | September 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. Individuals must be diagnosed with Dementia and/or memory loss by a clinician. 2. 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). 3. 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. 4. Individuals must be able to walk or stand with or without personnel or assistive devices. 5. Individuals must be greater than or equal to 50 years of age. Exclusion Criteria: - 1. 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. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Unviersity | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Activities-Specified Balance Confidence (ABC) scale | A patient-reported questionnaire regarding balance confidence during 16 everyday activities. The ABC scale is quick and easy to administer and has demonstrated good reliability, validity, and sensitivity | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Mini-Balance Evaluation Systems Test (M-BESTest) | A sensitive, reliable, valid, and sensitive 14-item scale that assesses dynamic balance [30]. It includes components evaluating anticipatory postural adjustments, responses to perturbation, sensory orientation and dynamic stability during gait. The total score ranges from 0 ("no balance") to 28 ("complete balance"). Each task on the M-BESTest will be scored from 0-2, which correspond to normal, moderate or severe inability to perform the task. In order to complete this test TemperĀ® foam (4 inches thick, medium density T41 firmness rating), chair without arm rests or wheels, incline ramp, stopwatch, a box (9" height) and a 3-meter distance measured out and marked on the floor with tape [from chair] will be required. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Balance Assessment test | Assesses the capacity of an individual to control center of gravity (COG) within their base of support. While standing on a force platform, subjects are asked to move a cursor indicating their COG from a center target to a peripheral target and back as quickly as possible while minimizing deviation. The process is repeated three times for each of nine peripheral targets in a random order with 30 second rests between each target presentation. Outcome measures derived from the test include movement reaction time (RT) movement velocity (MV), maximum COG excursion (ME), end point COG excursion (EE), and directional control (DC). These LS measures are all impaired in fallers compared to non-fallers [32]. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Geriatric Anxiety Inventory (GAI) | The GAI is a 20-item scale that screens for anxiety symptoms in adults aged 50 and over. It is designed to assess anxiety symptoms over the past week. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Cornell Scale for Depression in Dementia (CSDD) | The CSDD is a valid screening tool for depression in elderly individuals with and without dementia [34]. This is a 19-item scale that it's designed to assess depressive symptoms over the past week and is completed by the individual's appointed caregiver. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Associative memory | Associative memory will be assessed using a face-word association task adapted from Wu et al. [13]. In this task, participants will be presented with 12 different pictures of human faces for 12s each. With each face, a common word will be presented, making a face-word pair. The participants will be instructed to memorize the face-word pairs. After a one-minute break, participants were again showed the same faces in a randomized order without the associated word. Participants were asked to recall the unique common word that was presented with each face. The number of successful answers will be summed as the associative memory score. Participants repeated this task twice, with a three-minute interval between each attempt. The average score of the two trials was used as the final associative memory score. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Montreal Cognitive Assessment (MOCA) | The MOCA is a tool used to assess cognitive impairment [35]. It assesses various aspects of cognition including executive function, memory, language, attention, and orientation. A score less than 25 out of 30 is considered significant for MCI. | At baseline 1-2 days pre-intervention, and 1-2 days post-intervention | |
Secondary | Frequency of Falls | Frequency of Falls: This questionnaire is composed of a single question that asks the number of falls experienced in the past 6 months. In the event that the SDM provides consent, they will be asked for a response to this questionnaire. In the event that the participant provides direct consent they will be asked to answer the question posed on the questionnaire. The researcher will additionally reach out to the family member/caregiver identified on the assent form to acquire this information. In the case of discrepant responses between the participant and the family member/caregiver we will use the response provided by the latter. | At baseline 1-2 days pre-intervention, 6 months post-intervention |
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