Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

NCT05839535 | Recruiting Phase 2 DMC

• 1 other identifier: 2023P000908
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• M1 resting state functional connectivity

  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/)

  Baseline, post-treatment (12 weeks)

Secondary Outcomes (9)

• Change on Cerebral blood flow

  Baseline, post-treatment (12 weeks)

• Change on M1 corticospinal excitability and cortico-cortical excitability

  Baseline, post-treatment (12 weeks)

• Change on brain gray matter volume

  Baseline, post-treatment (12 weeks)

• Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, post-treatment (12 weeks), follow-up (24 weeks)

• Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29

  Baseline, post-treatment (12 weeks), follow-up (24 weeks)

Study Arms (4)

BDJ + real tDCS

ACTIVE COMPARATOR

Behavioral: BDJ; Device: tDCS

Exercise + real tDCS

ACTIVE COMPARATOR

Device: tDCS; Other: exercise

BDJ + sham tDCS

ACTIVE COMPARATOR

Behavioral: BDJ; Device: sham tDCS

Exercise + sham tDCS

ACTIVE COMPARATOR

Device: sham tDCS; Other: exercise

Interventions

BDJ BEHAVIORAL

BDJ is a mind-body intervention

BDJ + real tDCS; BDJ + sham tDCS

tDCS DEVICE

tDCS is a brain stimulation method.

BDJ + real tDCS; Exercise + real tDCS

sham tDCS DEVICE

sham tDCS

BDJ + sham tDCS; Exercise + sham tDCS

exercise OTHER

exercise including stretching and other activities.

Exercise + real tDCS; Exercise + sham tDCS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers 45-75 years of age
• Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
• Physically able to participate in the BDJ and stretching control education programs
• Willing to complete the 12-week study
• Can participate in MRI scan
• Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures

You may not qualify if:

• Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
• Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
• Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
• Patient Mini-Mental Status Examination score below 24 \[293\]
• Unable to walk without a cane or other assistive device
• The intent to undergo surgery during the time of involvement in the study
• Plan to permanently relocate from the region during the trial period

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcranial Direct Current Stimulation; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jian Kong

CONTACT

617-7267893; jkong2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Clinical mechanism study

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 3, 2023
• Study Start: March 5, 2024
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)