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

Must not have

Presence of other medically unstable condition (e.g., uncontrolled diabetes with recent weight loss, diabetic coma, frequent insulin reactions)

Cognitive and/or attention difficulties affecting participant's ability to follow study directions

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled medical conditions like severe diabetes.

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I have trouble focusing or remembering, which may affect my ability to follow study instructions.

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I do not have any skin issues or wounds on my scalp where an EEG would be placed.

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I have a history of heart problems like heart attack or heart failure.

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.