Effects of Theta Burst Stimulation on Pain and Cognition in Older Adults

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.

This study is testing whether a new brain stimulation technique can help older adults with chronic pain feel better and think more clearly.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06709963 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function in older adults suffering from chronic musculoskeletal pain. Participants will receive a series of iTBS sessions over 14 days, and their brain activity will be monitored using MRI scans to understand the neurophysiological mechanisms involved. The study aims to determine the effectiveness of iTBS in alleviating pain and enhancing cognitive abilities in this demographic.

Who should consider this trial

Good fit: Ideal candidates are older adults with chronic nonspecific low back pain or chronic knee pain, who have normal cognitive function and meet specific educational and communication criteria.

Not a fit: Patients with specific causes of chronic pain or those unable to ambulate without assistance may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management and cognitive function in older adults with chronic musculoskeletal pain.

How similar studies have performed: While the use of iTBS is a relatively novel approach, preliminary studies have shown promise in similar applications, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 26)
* be right-handed
* be able to speak Cantonese
* chronic nonspecific low back pain, or having both chronic nonspecific low back pain and chronic knee pain that has lasted for at least 3 months
* an average pain intensity of ≥ 5 out of 10 on an 11-point numerical rating scale in the last 7 days, where 0 means "no pain" and 10 means "worst pain imaginable"
* having pain at least half of the days in the past 4 weeks.
* have at least 6 years of formal education and know how to read and write Chinese
* agree to sign an informed consent and complete the experiment tests
* be able to communicate via email or text message, as several study measures will be collected electronically

Exclusion Criteria:

* inability to ambulate without assistance from another person (canes or walkers will be allowed);
* having specific causes of chronic nonspecific low back pain, or having both chronic nonspecific low back pain and chronic knee pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
* having other concurrent musculoskeletal conditions at other body parts (e.g., fibromyalgia, or neck pain)
* self-reported history of lumbar or lower extremity surgery
* self-reported history of neurological or psychiatric disorders (e.g., stroke, brain surgery, head trauma; schizophrenia, multiple personality disorder, dissociative identity disorder, stroke) or self-reported cancer history
* self-reported specific inflammatory disorder: rheumatoid arthritis, rheumatica, scleroderma, lupus, or polymyositis
* unexplained, unintended weight loss of 20 lbs or more in the past year
* cauda equina syndrome
* uncorrected visual deficit
* drug or alcohol addiction
* taken alcohol, opioids or benzodiazepines medicines 24 hours before the experiment
* claustrophobia
* contraindications for undergoing the magnetic resonance imaging (MRI) examination based on the MRI safety screening form of University Research Facility in Behavioral and Systems Neuroscience (UBSN) at The Hong Kong Polytechnic University (PolyU)

Where this trial is running

Hong Kong

• The Hong Kong Polytechnic University — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Arnold Dr WONG — The Hong Kong Polytechnic University
• Study coordinator: Fan Dr. Huang

Conditions: Chronic Non-Specific Low Back Pain, Chronic Knee Pain, Chronic Musculoskeletal Pain, Chronic non-specific low back pain, rTMS, Sham, Chronic knee pain, DLPFC