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Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Study Purpose

Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - elective unilateral knee total replacement.
  • - mentally capable of reading, giving consent and following instructions.
  • - being able to answer questions in English.
  • - not pregnant.

Exclusion Criteria:

  • - history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation.
  • - systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia.
  • - alcohol/substance abuse.
  • - current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists.
  • - hospitalization within the preceding year for psychiatric illness.
- no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05673720
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Florida State University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Additional Details

The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

Arms & Interventions

Arms

Experimental: preoperative active tDCS+MBI

Active tDCS with simultaneous meditation intervention will be applied.

Sham Comparator: preoperative sham tDCS+MBI

Sham tDCS with simultaneous sham MBM intervention will be delivered.

Interventions

Device: - active tDCS paired with active MBM

Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.

Device: - sham tDCS paired with sham MBM

For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tallahassee Orthopedic Clinic, Tallahassee, Florida

Status

Recruiting

Address

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32308

Site Contact

Phillip Worts, PhD

[email protected]

904-735-4961

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