COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain

Quick Facts

Study Start:2023-07-01
Study Completion:2025-08-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05880251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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,
  2. * Male or female age 18 years or older,
  3. * Medical clearance to participate,
  4. * Reasonable expectation that ongoing medications, if any, will be maintained without change for at least 4 months from the start of the study,
  5. * Able to provide informed consent and to understand the study instructions,
  6. * Able to participate in the specific study procedures.
  1. * Presence of other medically unstable and/or infectious condition (e.g., uncontrolled diabetes with recent weight loss, diabetic coma, frequent insulin reactions),
  2. * A cardiac condition (e.g., history of myocardial infarction or congestive heart failure),
  3. * Cognitive and/or attention difficulties affecting participant's ability to follow study directions,
  4. * Known skin disorders or damaged skin at the anticipated at the scalp for EEG recording (e.g., unhealed wounds, broken skin).
  5. * Metal implants above the chest

Contacts and Locations

Principal Investigator

Jodi A Brangaccio, PT
PRINCIPAL_INVESTIGATOR
Albany VA Medical Center Samuel S. Stratton, Albany, NY

Study Locations (Sites)

Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, 12208-3410
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jodi A Brangaccio, PT, PRINCIPAL_INVESTIGATOR, Albany VA Medical Center Samuel S. Stratton, Albany, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2025-08-29

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2025-08-29

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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