Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)
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|ClinicalTrials.gov Identifier: NCT02493842|
Recruitment Status : Unknown
Verified August 2016 by Aalborg Universitetshospital.
Recruitment status was: Recruiting
First Posted : July 10, 2015
Last Update Posted : August 9, 2016
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Transverse Intrafasicular Multichannel electrode (TIME)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Sensory Feedback for Phantom Limb Modulation and Therapy|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Invasive nerve stimulation
Invasive nerve stimulation using the following experimental devices
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)
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.
- Phantom limb pain [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]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)
- Cortical reorganization [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]The cortical response to peripheral stimulation will be tracked using MRI MRI and EEG.
- Cortical reorganization [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]The cortical response to peripheral stimulation will be tracked using EEG
- Phantom limb pain [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]The pain symptoms wil be assessed using the neuropatic pain symptom inventory (NPSI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493842
|Contact: Preben Sørensen, MD||97660000 ext +email@example.com|
|Contact: Kristian R Harreby, PhD||99407520 ext +firstname.lastname@example.org|
|Aalborg University Hospital||Recruiting|
|Aalborg, Nordjylland, Denmark, 9000|
|Contact: Preben Sørensen, MD 97660000 ext +45 email@example.com|
|Contact: Kristian R Harreby, PhD 99407520 ext +45 firstname.lastname@example.org|
|Principal Investigator:||Preben Sørensen, MD||Aalborg Universitetshospital|