Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Location status: Recruiting
NCT Number: NCT05839535
This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.
Interested in participating?
Request Info45 year–75 year
All sexes
Interventional
Phase 2
Charlestown, Massachusetts, 02129, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BDJ is a mind-body intervention
tDCS is a brain stimulation method.
sham tDCS
exercise including stretching and other activities.
Time frame: Baseline, post-treatment (12 weeks)
Changes in brain resting-state connectivity between the primary motor cortex (M1) and other brain regions pre- and post-treatments, analyzed using the CONN Toolbox (https://web.conn-toolbox.org/)
Time frame: Baseline, post-treatment (12 weeks)
Cerebral blood flow will be measured using arterial spin labeling (ASL)
Time frame: Baseline, post-treatment (12 weeks)
M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).
Time frame: Baseline, post-treatment (12 weeks)
Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
The KOOS is a 35-item self-administered survey of pain and function in knee OA patients.
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days.
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression.
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain.
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Pressure pain thresholds will be assessed 3 times using a Somedic digital pressure algometer. Contact heat stimuli will be delivered using a PATHWAY CHEPS (Contact Heat-Evoked Potential Stimulator, Medoc Advanced Medical Systems).
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
The 6-Minute Walk Test is a self-paced endurance test that assesses walking ability and endurance and includes standardized encouragement that increase tolerability in elders and those with physical impairment.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
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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