Actively Recruiting
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.
Led by The Hong Kong Polytechnic University · Updated on 2025-01-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function in older adults aged 60 to 85 who suffer from chronic musculoskeletal pain. This study also uses magnetic resonance imaging (MRI) to explore the brain mechanisms that might explain how iTBS influences these outcomes. The trial aims to determine if stimulating the left dorsolateral prefrontal cortex with accelerated iTBS is effective for this population and to understand the underlying neurophysiological changes. Participants will receive treatment using a device called the Cool-6000 A/P coil, which delivers real or sham iTBS to the scalp. Each day, participants will have two iTBS sessions spaced 15 minutes apart, with each session lasting about 30 minutes. The stimulation protocol includes 1,200 pulses per day over a total of 14 days, with an intensity set at 70% of the resting motor threshold. This study is randomized, with participants assigned to either real iTBS or sham control groups. Throughout the study, participants will undergo MRI scans before and immediately after the treatment period. They will also complete various tests measuring cognitive function and pain before, right after treatment, and at follow-up intervals including one, three, and six months post-treatment. Researchers will assess outcomes such as pain intensity, cognitive abilities, depression, anxiety, physical activity, sleep quality, and frailty. Safety and acceptability of the iTBS treatment will also be monitored, with the entire participation lasting up to six months for follow-up assessments.
CONDITIONS
Brief Title
The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have normal cognitive function (Hong Kong Montreal Cognitive Assessment score 65)
- Be right-handed
- Be able to speak Cantonese
- Have chronic nonspecific low back pain, or both chronic nonspecific low back pain and chronic knee pain lasting at least 3 months
- Have an average pain intensity of 65 5 out of 10 in the last 7 days
- Have pain on at least half of the days in the past 4 weeks
- Have at least 6 years of formal education and be able to read and write Chinese
- Agree to sign informed consent and complete study tests
- Be able to communicate via email or text message
You will not qualify if you...
- Inability to walk without assistance (canes or walkers allowed)
- Specific causes of low back pain like spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, or spinal infection
- Other musculoskeletal conditions such as fibromyalgia or neck pain
- History of lumbar or lower extremity surgery
- History of neurological or psychiatric disorders including stroke, brain surgery, head trauma, schizophrenia, multiple personality disorder, dissociative identity disorder, or cancer
- Specific inflammatory disorders like rheumatoid arthritis, rheumatica, scleroderma, lupus, or polymyositis
- Unexplained weight loss of 20 lbs or more in the past year
- Cauda equina syndrome
- Uncorrected vision problems
- Drug or alcohol addiction
- Use of alcohol, opioids, or benzodiazepines within 24 hours before the experiment
- Claustrophobia
- Contraindications for MRI based on safety screening at the research facility
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants undergo intermittent theta burst stimulation (iTBS) sessions targeting brain characteristics, pain intensity, and cognitive functions. Each treatment day includes two iTBS sessions with a 15-minute interval, lasting about 30 minutes per session.
14 treatment visits (in-person)
Duration - 6 months
Participants are followed for up to six months after treatment to assess sustained effects on pain intensity, cognitive functions, and other health measures.
Multiple follow-up visits at 1 month, 3 months, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Actively Recruiting
Research Team
F
Fan Dr. Huang
Y
Yat Ching Miss Wong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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