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Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation (OCS-PLP)

Primary Purpose

Phantom Limb Pain After Amputation, Lower Limb Amputation, Upper Limb Amputation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operant Conditioning with Peripheral Stimulation
Control Group with Peripheral Stimulation Only
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain After Amputation focused on measuring Phantom limb pain, Amputation, Operant Conditioning, Brain-Computer Interface, Electroencephalography, Tactile sense, Instrumental learning, Event Related Potentials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Albany VA Medical Center Samuel S. Stratton, Albany, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

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

Control group receives peripheral stimulation but without operant conditioning feedback.

Outcomes

Primary Outcome Measures

Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)
The Sf-MPQ assesses the pain quality in the sensory (11 items) and affective (4 items) dimensions. Each item is rated on an intensity scale of 0 (none) to 3 (severe). Total score is obtained by summing the scores for all items and the range is 0 (no pain) to 45 (severe pain).
Change in Somatosensory Evoked Potential (SSEP) Amplitude as Measured by a Tactile Event Related Potential Test
The evoked response to tactile stimuli will be captured with 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. An increase in amplitude will indicate improvement in the sensorimotor cortical response.
Change in Somatosensory Evoked Potential (SSEP) Latency as Measured by a Tactile Event Related Potential Test
The evoked response to tactile stimuli will be captured with 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. A reduction in latency will indicate improvement in the sensorimotor cortical response.

Secondary Outcome Measures

Change in Impact of Pain on Quality of Life as Measured by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)
This is a 52-item inventory with 12 subscales over 3 domains. Each item is scored on a 0-6 scale. Scores for each subscale are obtained by taking the mean of the scores of all items in that subscale. Higher scores indicate more severity in that subscale. Part I includes five scales designed to measure important dimensions of the chronic pain experience; Part II assesses patients' perceptions of the degree to which spouses or significant others display Solicitous, Distracting or Negative responses to their pain behaviors and complaints. Part III assesses patients' report of the frequency with which they engage in four categories of common everyday activities; Household Chores, Outdoor Work, Activities Away from Home, and Social Activities.

Full Information

First Posted
May 9, 2023
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05880251
Brief Title
Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation
Acronym
OCS-PLP
Official Title
Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 a brain response. Electrodes will be placed on the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to 2 groups, one group receiving the operant conditioning feedback with peripheral stimulation (Intervention group) and the other receiving only peripheral stimulation with no operant conditioning feedback (Control group).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The pre and post clinical assessment will be performed by a blinded evaluator. The participant will not be told about group assignment till the end of the last follow-up session and assessment Investigators will keep blinded to the baseline clinical measures.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group receives peripheral stimulation with realtime operant conditioning feedback training.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Control group receives peripheral stimulation but without operant conditioning feedback.
Intervention Type
Behavioral
Intervention Name(s)
Operant Conditioning with Peripheral Stimulation
Intervention Description
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
Intervention Name(s)
Control Group with Peripheral Stimulation Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)
Description
The Sf-MPQ assesses the pain quality in the sensory (11 items) and affective (4 items) dimensions. Each item is rated on an intensity scale of 0 (none) to 3 (severe). Total score is obtained by summing the scores for all items and the range is 0 (no pain) to 45 (severe pain).
Time Frame
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
Title
Change in Somatosensory Evoked Potential (SSEP) Amplitude as Measured by a Tactile Event Related Potential Test
Description
The evoked response to tactile stimuli will be captured with 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. An increase in amplitude will indicate improvement in the sensorimotor cortical response.
Time Frame
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
Title
Change in Somatosensory Evoked Potential (SSEP) Latency as Measured by a Tactile Event Related Potential Test
Description
The evoked response to tactile stimuli will be captured with 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. A reduction in latency will indicate improvement in the sensorimotor cortical response.
Time Frame
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
Secondary Outcome Measure Information:
Title
Change in Impact of Pain on Quality of Life as Measured by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)
Description
This is a 52-item inventory with 12 subscales over 3 domains. Each item is scored on a 0-6 scale. Scores for each subscale are obtained by taking the mean of the scores of all items in that subscale. Higher scores indicate more severity in that subscale. Part I includes five scales designed to measure important dimensions of the chronic pain experience; Part II assesses patients' perceptions of the degree to which spouses or significant others display Solicitous, Distracting or Negative responses to their pain behaviors and complaints. Part III assesses patients' report of the frequency with which they engage in four categories of common everyday activities; Household Chores, Outdoor Work, Activities Away from Home, and Social Activities.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jodi A Brangaccio, PT
Phone
(518) 626-5636
Email
Jodi.Brangaccio@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Disha Gupta, PhD
Phone
(518) 626-7363
Email
Disha.Gupta@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodi A Brangaccio, PT
Organizational Affiliation
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany VA Medical Center Samuel S. Stratton, Albany, NY
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi A Brangaccio, PT
Phone
518-626-5636
Email
Jodi.Brangaccio@va.gov
First Name & Middle Initial & Last Name & Degree
Disha Gupta, PhD
Phone
(518) 626-7363
Email
Disha.Gupta@va.gov
First Name & Middle Initial & Last Name & Degree
Jodi A Brangaccio, PT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24672441
Citation
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.
Results Reference
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Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation

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