← Back to Search

Behavioral Intervention

Operant Conditioning for Phantom Limb Pain (OCS-PLP Trial)

N/A

Recruiting

Led By Jodi A Brangaccio, PT

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

An upper (or lower limb) amputation more than 6 months ago, that has produced a moderate to severe hand/arm (or foot/leg) phantom limb pain

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends

Awards & highlights

OCS-PLP Trial Summary

This trial will investigate a new way to reduce phantom limb pain, which affects 60-90% of amputees. The approach uses realtime feedback of brain responses to promote normal sensorimotor reorganization. Goal: reduce PLP & its effects.

Who is the study for?

This trial is for adults over 18 who've had an arm or leg amputated more than 6 months ago and suffer from moderate to severe phantom limb pain. They should be stable on current medications, if any, able to follow study instructions, and have medical clearance. Those with heart conditions, unstable health issues like uncontrolled diabetes, cognitive difficulties, skin disorders at the EEG site, or metal implants above the chest cannot join.Check my eligibility

What is being tested?

The study tests a non-drug technique called operant conditioning alongside peripheral stimulation to reduce phantom limb pain in amputees. Participants will receive real-time brain feedback aimed at normalizing sensorimotor responses. The control group receives only peripheral stimulation without this targeted brain training.See study design

What are the potential side effects?

Since it's a non-pharmacological approach focusing on behavioral therapy and electrical stimulation of nerves through the skin (peripheral), side effects might include discomfort or skin irritation where electrodes are placed for EEG recording and peripheral stimulation.

OCS-PLP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had an arm or leg amputation over 6 months ago and suffer from severe phantom limb pain.

OCS-PLP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)

Change in Somatosensory Evoked Potential (SSEP) Amplitude as Measured by a Tactile Event Related Potential Test

Change in Somatosensory Evoked Potential (SSEP) Latency as Measured by a Tactile Event Related Potential Test

Secondary outcome measures

Change in Impact of Pain on Quality of Life as Measured by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)

OCS-PLP Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

Intervention group receives peripheral stimulation with realtime operant conditioning feedback training.

Group II: Control GroupExperimental Treatment1 Intervention

Control group receives peripheral stimulation but without operant conditioning feedback.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,612 Previous Clinical Trials

3,305,723 Total Patients Enrolled

Jodi A Brangaccio, PTPrincipal InvestigatorAlbany VA Medical Center Samuel S. Stratton, Albany, NY

Media Library

Operant Conditioning with Peripheral Stimulation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05880251 — N/A

Lower Limb Amputation Research Study Groups: Intervention Group, Control Group

Lower Limb Amputation Clinical Trial 2023: Operant Conditioning with Peripheral Stimulation Highlights & Side Effects. Trial Name: NCT05880251 — N/A

Operant Conditioning with Peripheral Stimulation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880251 — N/A

Frequently Asked Questions

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

Are there opportunities to join this medical experiment at present?

"As evident on clinicaltrials.gov, this trial is not presently accepting candidates; applicants were first invited to partake in the study on August 1st, 2023 and updates stopped coming through as of May 18th, 2023. Nevertheless, 443 other medical studies are actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation

2023. "Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880251.