The Hong Kong Polytechnic University
Hong Kong
Location status: Recruiting
NCT Number: NCT06709963
The goal of this clinical trial is to explore the effects of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function in older adults with chronic musculoskeletal pain. It will also utilize magnetic resonance imaging to illustrate the neurophysiological mechanisms underlying the role of iTBS in improving various outcome indicators in this population.
The main questions it aims to answer are:
1. Is left dorsolateral prefrontal cortex stimulation using accelerated iTBS effective for older adults with chronic musculoskeletal pain? 2. What are the neurophysiological mechanisms underlying the role of iTBS in improving various outcome indicators in older adults with chronic musculoskeletal pain?
Participants will:
1. Receive 1,200 stimuli during a single-session iTBS, totaling 14 days. 2. Undergo MRI scanning before, immediately after treatment, cognitive and pain-related tests before, immediately after treatment, and during follow-up.
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We will use a coil called Cool-6000 A/P to conduct real and sham control. This coil will be placed on the scalp of older adults. The iTBS protocol will begin with a 2-s burst train (totally 30 pulses), repeating every 10 s. Each burst train will consist of 10 triplet pulses with an inter-burst interval of 0.16 s, thus the triplets fire at a rate of 5 Hz. ITBS parameters will include three continuous pulses at 50 Hz repeated at 5 Hz (2s on, 8s off) for a total of 600 pulses.
We will administer two rounds of iTBS per treatment day, with a 15-minute interval between the two sessions. In total, each participant will receive 1,200 stimuli during a single-session iTBS, totaling for 14 days. Each treatment session will last for about 30 minutes. Intermittent θ-burst stimulation intensity will be set at 70% of the resting motor threshold.
Time frame: Immediately after the intervention
The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate will be evaluated as our primary outcomes, because of the feasibility of the study.
Time frame: Immediately after the intervention
ITBS acceptability questionnaire has ten items of positive acceptability, ranged from 10 to 50, and it also has five items of negative acceptability, ranged from 5 to 25. The iTBS acceptability questionnaire has a total score ranging from 15 to 75.
Time frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
The 11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Time frame: Baseline
The Chinese version of the short Depression Anxiety Stress Scales, scores ranged from 0 to 13, higher scores for each domain (depression, anxiety, and stress) indicate more respective problems.
Time frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
The Hong Kong Chinese Version of the Roland-Morris Disability Questionnaire has 24 items. Scores ranged from 0 to 24, higher scores indicate worse disability.
Time frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.
Time frame: Baseline
The body map scoring system indicates the location of participants' painful site
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Fatigue, Resistance, Ambulation, Illness, and Loss, the presence of 3 of 5 item characteristics indicate the presence of frailty, scores ranged from 0 to 5. Lower scores mean more frailty.
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Physical Activity Scale for the Elderly; it has 3 domains (leisure, household, and occupation activities) to measure physical activity levels of adults aged 65 or above. higher scores indicate more active.
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Pittsburgh Sleep Quality Index. It has 7 domains to measure sleep quality , sleep latency, sleep duration, habital sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Scores ranged from 0 to 21, higher scores indicate poorer sleep quality.
Time frame: Baseline
Hong Kong Montreal Cognitive Assessment. It is a cognitive screening tool specifically adapted for Chinese older adults in Hong Kong. It is designed to detect mild cognitive impairment and dementia. A score < 26 suggests participant has mild cognitive impairment.
Time frame: Baseline, immediately after the intervention
The digit 2-back task, more response accuracy of digits indicates better working memory
Time frame: Baseline, immediately after the intervention.
The More Odd Shifting task, It requires participants to switch between different mental sets or rules, such as identifying odd numbers or shifting between different categories. Better response accuracy indicates better cognitive flexibility
Time frame: Baseline, immediately after the intervention.
Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
The Verbal Digits Forward and Backward Test, more correct recall of digits indicate better working memory and executive function
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
The Trail Making Tests, a neuropsychological test of visual attention and task switching, completing the trail correctly within a shorter period of time means better cognitive flexibility
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Go/NoGo task, more response accuracy indicates better control of inhibition.
Contact information is provided by the study sponsor or research team.
Fan Dr. Huang
CONTACT
Yat Ching Miss Wong
CONTACT
The Hong Kong Polytechnic University
Other
The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain: a Double-blinded, Randomized, Sham-controlled, Mixed-methods, Pilot Trial with a Six-month Post-treatment Follow-up.
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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