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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Fan Dr. Huang
fan2023.huang@connect.polyu.hk
+852 5303 7752
Backup
Yat Ching Miss Wong
yatching.wong@connect.polyu.hk
+852 60799195
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Sham_comparator: Sham
Experimental: Left DLPFC
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov