Direct Nerve Stimulation for Treatment of Phantom Limb Pain

NCT02493842 | Unknown DMC

• 2 other identifiers: EPIONE-602547-5no. 602547
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not well known what causes PLP to develop and the current treatments have been shown to be largely ineffective. Resent research, however, have indicated that cortical reorganizing occurring after amputation of the cortex areas related to the missing limb may be related to the development of PLP. Furthermore, the research indicated that by providing meaningful sensory input coming from the phantom limb the PLP may be alleviated and the cortical organization normalized. Aim: The CIP described in the current application, is part of a the EU-project "EPIONE", which aims to investigate if and how cortical normalization and PLP alleviation can be induced by providing phantom limb sensations (sensations which seems to originate from the missing limb) in hand amputated subjects. Method: In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes in the arm stump for up to one year. Therapy will be evaluated in two stages, first during a standardized four week phase where the subject receives daily therapy. If the therapy is shown to be effective, therapy may be reinitiated during a second longer therapy phase. During the therapy sessions, selective nerve stimulation will be performed. The amputee will experience this as sensations (movement, touch, temperature, vibration etc.) originating from the phantom limb. While implanted, we will investigate how well we can induce these sensations and we will provide a stimulation therapy, which consist of stimulation activities which requires the subject to focus on the evoked sensations. Prior to, during a and following therapy a series of assessments (standardized across all EPIONE partners to enable comparison) will be conducted to relate therapy with PLP, cortical organization, the mental state etc. of the subject. Expected outcome: The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The experience we gain might be used for deriving clinical guidelines on how to treat PLP.

Conditions

Phantom Limb Pain

Keywords

Nerve Stimulation; Neuroplasticity; Sensory Feedback

Outcome Measures

Primary Outcomes (2)

• Phantom limb pain

  The pain intensity will be assessed using a visual analog scale (VAS) analog scale (VAS), the neuropatic pain sympton inventory (NPSI), the brief pain inventory interference scale (BPSI)

  Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)

• Cortical reorganization

  The cortical response to peripheral stimulation will be tracked using MRI MRI and EEG.

  Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)

Secondary Outcomes (2)

• Cortical reorganization

  Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)

• Phantom limb pain

  Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)

Study Arms (1)

Invasive nerve stimulation

EXPERIMENTAL

Invasive nerve stimulation using the following experimental devices 1. Transverse Intrafascicular Multichannel Electrode for human (TIME-4H) 2. The STIMEP stimulator 3. The EPIONE Psychophysical Testing Platform software for stimulator control Nerve stimulation therapy is provided while providing visual guidance to the subject and without the use of hand prosthetic devices

Device: Transverse Intrafasicular Multichannel electrode (TIME)

Interventions

Transverse Intrafasicular Multichannel electrode (TIME) DEVICE

Peripheral nerve stimulation is conducted with Transverse Intrafasicular Multichannel electrode (TIME) version 4 electrodes to induce sensory sensations from the phantom hand, while subject is virtualizing a movement or event which may cause the specific sensation.

Invasive nerve stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult man or woman \>18 yrs and \< 70 yrs.
• Unilateral transradial amputation.
• Other treatments for PLP tried with poor results
• Patient accepts the study protocol as explained by the physician.
• The subject must experience intractable PLP higher than 6 on a Visual Analog Scale (VAS) from 0-10. The frequency of PLP attacks must present itself more than once a week.
• Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from experiencing phantom pain is healthy and able to carry out the experiment.

You may not qualify if:

• Cognitive impairment
• Current or prior psychological impairments: major personality disturbance (i.e., borderline, antisocial), major depression, bipolar I.
• Pregnant (if fertile woman: assessed via a pregnancy test) or not using contraception accepted by the authorities during the study
• Breastfeeding women cannot participate in the study
• History of or active substance abuse disorder.
• Acquired brain injury with residual impairment
• Intellectual Disability (IQ \< 70)
• Current or prior neurological or musculoskeletal disease
• Current or prior dermatological conditions
• Persons with other diseases that may affect the function of the nervous system, e.g., diabetes, HIV or renal failure.
• Subjects who will not be able to have an fMRI examination conducted because of metal implants such as: pacemakers, artificial joints, bone screws.
• Subjects who suffer from claustrophobia and who are unable of having an fMRI examination conducted (the examination requires the subject to lie inside a narrow space in the MRI machine).
• Subjects cannot participate in other clinical studies and/or tests of medical devices

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator
• University of Lausanne Hospitals: collaborator
• University of Freiburg: collaborator
• Université Montpellier: collaborator
• Lund University: collaborator
• Indiana University School of Medicine: collaborator
• Novosense AB: collaborator
• Mxm-Obelia: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Universitat Autonoma de Barcelona: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Preben Sørensen, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Preben Sørensen, MD

CONTACT

97660000; prebsoe@rn.dk

Kristian R Harreby, PhD

CONTACT

99407520; krauhe@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 10, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

DK (1)