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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
Awards & highlights

tDCS-CBI Trial 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.Check my eligibility
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.See study design
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.

tDCS-CBI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
postoperative opiod pain medication use
Secondary outcome measures
Long term outcomes of patient reported pain ratings

tDCS-CBI 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
1,609 Previous Clinical Trials
3,306,471 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 Knee Replacement 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 Knee Replacement 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this experiment?

"Verified, the clinical trial is still open and seeking participants. According to records on clinicaltrials.gov, it was first posted in January 11th 2021 with its last edit being made on January 31st 2022. 132 volunteers are sought from one location for this research project."

Answered by AI

Does this clinical study accept applicants aged 30 and above?

"The eligibility criteria set out by this clinical trial stipulates that the minimum age of enrollment is 18, while the maximum age cap for patient participation is 90."

Answered by AI

Are there still vacancies within this clinical trial for participants?

"As indicated by clinicaltrials.gov, this medical trial is presently enrolling participants; the initial post was dated 11th of January 2021 and its most recent update happened at the end of January 2022."

Answered by AI

Could I be eligible to join this research project?

"This clinical investigation seeks to enrol 132 individuals who suffer from pain and are between 18-90 years old. To be considered, applicants must have the capacity to read, write, give consent, and abide by instructions; they will also need to possess clearance for unilateral TKA or THA surgery at Ralph H. Johnson VAMC in Charleston SC., as well as the capability of perceiving CB intervention through headphones while understanding educational material articulated in English. (132 participants would be recruited so that a 10% dropout rate can be accounted for)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of tDCS Combined With CBI on Postsurgical Pain
2021. "Effects of tDCS Combined With CBI on Postsurgical Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04199780.
~31 spots leftby Apr 2025
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