Phantom Limb Pain After AmputationOCS-PLPNCT05880251
Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation
A study testing Operant Conditioning with Peripheral Stimulation in people with Phantom Limb Pain After Amputation and Lower Limb Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain After Amputation, Lower Limb Amputation, Upper Limb Amputation
- What is being tested?
- Operant Conditioning with Peripheral Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, 12208-3410
About this study
Official title: Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain
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.
Read the 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
- Being tested
- Operant Conditioning with Peripheral Stimulation, Control Group with Peripheral Stimulation Only
- Keywords
- Phantom limb pain, Amputation, Operant Conditioning, Brain-Computer Interface, Electroencephalography, Tactile sense, Instrumental learning, Event Related Potentials
- Medical subject headings
- Phantom Limb, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant Conditioning with Peripheral StimulationBehavioural
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 with Peripheral Stimulation OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group receives peripheral stimulation with realtime operant conditioning feedback training. Receives: Behavioral: Operant Conditioning with Peripheral Stimulation |
| Control Group | Experimental | Control group receives peripheral stimulation but without operant conditioning feedback. Receives: Behavioral: Control Group with Peripheral Stimulation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Change in Evoked Potential (EP) Amplitude and threshhold
The evoked response to tactile stimuli will be captured in one of two ways 1) EMG and Reflex evoke responses from cutaneous nerve on the residual Limb and 2) 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 response and tolerance.
Measured: 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
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.
Measured: 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 outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb Pain After AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jodi A Brangaccio, PT, Principal investigator, Albany VA Medical Center Samuel S. Stratton, Albany, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880251
- Sponsor's protocol ID
- F4410-P
- Other IDs
- 1I21RX004410-01A1
- Acronym
- OCS-PLP
- Status last verified
- Jan 2026
- First submitted
- 9 May 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24672441
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT05880251
- Acronym / sponsor ID
- OCS-PLP / F4410-P
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Operant Conditioning with Peripheral StimulationIntervention group receives peripheral stimulation with realtime operant conditioning feedback training. |
| Control Group | Experimental | Behavioral: Control Group with Peripheral Stimulation OnlyControl group receives peripheral stimulation but without operant conditioning feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operant Conditioning with Peripheral StimulationThis 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. | Behavioural | Intervention Group |
| Control Group with Peripheral Stimulation OnlyThis 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. | Behavioural | Control Group |
Primary outcome
Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)
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
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 Evoked Potential (EP) Amplitude and threshhold
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
The evoked response to tactile stimuli will be captured in one of two ways 1) EMG and Reflex evoke responses from cutaneous nerve on the residual Limb and 2) 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 response and tolerance.
Change in Somatosensory Evoked Potential (SSEP) Latency as Measured by a Tactile Event Related Potential Test
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
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.
1 secondary outcome
Change in Impact of Pain on Quality of Life as Measured by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 24672441Thompson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodi A Brangaccio, PT principal investigator
Albany VA Medical Center Samuel S. Stratton, Albany, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operant Conditioning with Peripheral Stimulation in people with Phantom Limb Pain After Amputation and Lower Limb Amputation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ) (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.