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tDCS + Cognitive Behavioral Therapy for Postoperative Pain (tDCS-CBI Trial)

N/A
Recruiting
Led By Jeffrey J Borckardt, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial will help determine if a new medical technology, transcranial direct current stimulation, can help reduce post-operative pain when combined with a cognitive-behavioral intervention.

Who is the study for?
This trial is for veterans who can read, write, consent, and follow instructions. They must be cleared for and scheduled to have knee or hip replacement surgery at the Ralph H. Johnson VAMC in Charleston SC. Participants should understand English as the CB intervention is delivered through headphones.
What is being tested?
The study tests if transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique using mild electrical currents, combined with Cognitive-Behavioral interventions (CB) can reduce pain and opioid use after knee or hip replacement surgeries.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode sites on the scalp, itching, tingling during application, headache or fatigue post-treatment. The CBI typically does not have physical side effects but could cause emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
postoperative opioid pain medication use
Secondary study objectives
Long term outcomes of patient reported pain ratings

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3- sham tDCS and real CBIExperimental Treatment2 Interventions
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
Group II: Group 2- real tDCS and sham CBIExperimental Treatment2 Interventions
4 active treatments of tDCS and education-only-control cognitive intervention
Group III: Group 1- real tDCS and real CBIExperimental Treatment2 Interventions
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
Group IV: Group 4- sham tDCS and sham CBIPlacebo Group2 Interventions
4 sham treatments of tDCS and education-only-control cognitive intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,537 Total Patients Enrolled
Jeffrey J Borckardt, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
2 Previous Clinical Trials
147 Total Patients Enrolled

Media Library

Cognitive-Behavioral (CB) intervention Clinical Trial Eligibility Overview. Trial Name: NCT04199780 — N/A
Total Hip Replacement Surgery Research Study Groups: Group 3- sham tDCS and real CBI, Group 4- sham tDCS and sham CBI, Group 1- real tDCS and real CBI, Group 2- real tDCS and sham CBI
Total Hip Replacement Surgery Clinical Trial 2023: Cognitive-Behavioral (CB) intervention Highlights & Side Effects. Trial Name: NCT04199780 — N/A
Cognitive-Behavioral (CB) intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199780 — N/A
~27 spots leftby Jan 2026
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