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

NCT ID: NCT05880251

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-08-29

Brief Summary

The study will investigate the application of a non-pharmacological operant conditioning approach to reduce phantom limb pain (PLP). PLP afflicts 60-90% people who have lost a limb. It can last for years and lead to drug dependence, job loss, and poor quality of life. Current non-pharmacological interventions are encouraging but limited, and their efficacy remains unclear. Limb amputation is known to lead to abnormal sensorimotor reorganization in the brain. Multiple studies have shown that PLP severity is correlated with the extent of this reorganization. The current study will train participants via realtime feedback of brain responses to promote more normal sensorimotor response, with the goal to reduce phantom limb pain.

Detailed Description

The study will be recruiting people who have had a limb amputation (traumatic or atraumatic) and are experiencing chronic phantom limb pain (PLP). Participants will be asked to be seated during the study session. Non-painful peripheral stimulation will be applied to elicit an evoked response (from either muscle or brain). Electrodes will be placed on the muscles and or scalp to record these electrical brain responses during the study session. Visual feedback based on the response will be provided in pseudo realtime. The study will involve three 1-hour sessions per week for 8-9 weeks, followed by 2 follow-up sessions at 3 and 6 months after the last session. Assessments of pain intensity and quality, and neurophysiological sensorimotor response, will be performed before the first session, after the last session, and at follow-up sessions. Additional electroencephalography (EEG) based assessments will also be performed as exploratory measures, to assess inter- and intra- hemispheric functional connectivity and sensorimotor responses associated with amputation and operant conditioning training.

Conditions

Phantom Limb Pain After Amputation; Lower Limb Amputation; Upper Limb Amputation; Phantom Pain; Chronic Pain

Keywords

Phantom limb pain; Amputation; Operant Conditioning; Brain-Computer Interface; Electroencephalography; Tactile sense; Instrumental learning; Event Related Potentials

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Operant Conditioning with Peripheral Stimulation

Intervention Type: BEHAVIORAL

This is a training intervention to strengthen the weakened sensorimotor responses and reduce pain, after a limb amputation. Non-painful peripheral stimulation will be applied to elicit a response.

Control Group

Control group receives peripheral stimulation but without operant conditioning feedback.

Group Type: EXPERIMENTAL

Control Group with Peripheral Stimulation Only

Intervention Type: BEHAVIORAL

This is a control intervention in which the non-painful peripheral stimulation will be applied, same as the operant conditioning group, but no training feedback will be provided.

Interventions

Operant Conditioning with Peripheral Stimulation

This is a training intervention to strengthen the weakened sensorimotor responses and reduce pain, after a limb amputation. Non-painful peripheral stimulation will be applied to elicit a response.

Intervention Type: BEHAVIORAL

Control Group with Peripheral Stimulation Only

This is a control intervention in which the non-painful peripheral stimulation will be applied, same as the operant conditioning group, but no training feedback will be provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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,
• Male or female age 18 years or older,
• Medical clearance to participate,
• Reasonable expectation that ongoing medications, if any, will be maintained without change for at least 4 months from the start of the study,
• Able to provide informed consent and to understand the study instructions,
• Able to participate in the specific study procedures.

Exclusion Criteria

• Presence of other medically unstable and/or infectious condition (e.g., uncontrolled diabetes with recent weight loss, diabetic coma, frequent insulin reactions),
• A cardiac condition (e.g., history of myocardial infarction or congestive heart failure),
• Cognitive and/or attention difficulties affecting participant's ability to follow study directions,
• Known skin disorders or damaged skin at the anticipated at the scalp for EEG recording (e.g., unhealed wounds, broken skin).
• Metal implants above the chest

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jodi A Brangaccio, PT

Role: PRINCIPAL_INVESTIGATOR

Albany VA Medical Center Samuel S. Stratton, Albany, NY

Locations

Albany VA Medical Center Samuel S. Stratton, Albany, NY

Albany, New York, United States

Countries

United States

References

Thompson AK, Wolpaw JR. Operant conditioning of spinal reflexes: from basic science to clinical therapy. Front Integr Neurosci. 2014 Mar 18;8:25. doi: 10.3389/fnint.2014.00025. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24672441 (View on PubMed)

Other Identifiers

F4410-P

Identifier Type: -

Identifier Source: org_study_id

1I21RX004410-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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