Using brain feedback to reduce phantom limb pain in amputees
Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain
This study is testing a new way to help amputees reduce phantom limb pain by using brain feedback and gentle stimulation over several weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT05880251 on ClinicalTrials.gov |
What this trial studies
This study investigates a non-pharmacological operant conditioning approach to alleviate phantom limb pain (PLP) in individuals who have undergone limb amputation. Participants will receive non-painful peripheral stimulation while their brain responses are recorded using electroencephalography (EEG). They will receive real-time visual feedback to help promote normal sensorimotor responses over three sessions per week for 8-9 weeks, followed by follow-up assessments at 3 and 6 months. The study aims to evaluate the effectiveness of this method in reducing pain intensity and improving quality of life for those affected by PLP.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older who have experienced a limb amputation more than 6 months ago and suffer from moderate to severe phantom limb pain.
Not a fit: Patients with unstable medical conditions, cognitive difficulties, or skin disorders affecting EEG recording may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce phantom limb pain and improve the quality of life for amputees.
How similar studies have performed: While similar non-pharmacological interventions have shown promise, this specific operant conditioning approach using real-time brain feedback is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Albany, New York
- Albany VA Medical Center Samuel S. Stratton, Albany, NY — Albany, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jodi A Brangaccio, PT — Albany VA Medical Center Samuel S. Stratton, Albany, NY
- Study coordinator: Jodi A Brangaccio, PT
- Email: Jodi.Brangaccio@va.gov
- Phone: (518) 626-5636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.