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Surface Electrical Stimulation for Treatment of Phantom Limb Pain (EPIONE)

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ClinicalTrials.gov Identifier: NCT02519907
Recruitment Status : Active, not recruiting
First Posted : August 11, 2015
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
Aalborg University
Aalborg Universitetshospital
University of Lausanne Hospitals
Université Montpellier
Lund University
Novosense AB
Mxm-Obelia
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Ken Yoshida, Indiana University

July 30, 2015
August 11, 2015
January 12, 2018
September 2015
October 2017   (Final data collection date for primary outcome measure)
  • Phantom limb pain [ Time Frame: Change in pain perception from baseline to three months ]
    The pain intensity will be assessed using visual analog scale (VAS)
  • Cortical reorganization [ Time Frame: Change in pain perception from baseline to three months ]
    The cortical response to peripheral stimulation will be tracked using MRI
Same as current
Complete list of historical versions of study NCT02519907 on ClinicalTrials.gov Archive Site
Phantom limb pain [ Time Frame: Change in neuropathic pain symptoms from baseline to three months ]
The pain symptoms will be assessed using the neuropathic pain symptom inventory (NPSI)
Same as current
Not Provided
Not Provided
 
Surface Electrical Stimulation for Treatment of Phantom Limb Pain
Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective.

Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback.

The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

Purpose of the Study. Up to 50-80 % of persons with amputations experience pain in the part of the body that is missing. This phenomenon is called phantom limb pain (PLP). It is not clear today why phantom limb pain occurs, and since the pain can be difficult to treat, it can affect the quality of life. Other scientific studies have shown that the use of electrical stimulation applied through surface electrodes can assist to decrease or alleviate the phantom limb pain. The aim of this study is to investigate if daily electrical stimulation for a period of 30 days can decrease or alleviate PLP.

Methods: This study is conducted in the following phases:

  1. Pre-screening
  2. Baseline
  3. Entry
  4. Pre-Therapy
  5. Therapy
  6. Outcome
  7. Follow-up

Procedures during phases 1 to 7 are standardized across international EPIONE partner (which carry out different interventions, but similar assessments), to enable comparison between treatment modalities.

During the different phases of the study a collection of assessment methods are conducted to monitor the effect of stimulation therapy on the amputee's level of perceived PLP and cortical organization. In addition, the psychological state of the subject, the strength and type of the non-painful phantom limb sensations are also assessed to provide a more detailed view on the possible effects of the stimulation therapy.

The experiment will be conducted as a series of case studies where the effect of the stimulation therapy in a subject is compared with the PLP sensations the same subjects perceived before initiating the therapy. Therefore, only amputees who are in a stable state (e.g.,not newly amputated subjects) are included in the study.

No placebo or blinding is performed as the amputee can feel the stimulation and also has to be mentally actively involved in performing "phantom limb movements" when receiving stimulation therapy.

Phases 1-7 for each subject (week -3 to week 12, week = 0 is pre-therapy) are performed according to the experiment protocol defined in collaboration with international partners.

Phase 1: Pre-screening. The pre-screen phase aims to assess the candidate subject for degree and duration of pain, intelligence and psychological state to test these measures against the inclusion criteria. The assessment protocol is administered once per subject prior to enrollment into the study.

Phase 2: Baseline. The baseline phase aims to determine the stability and intra-subject variability of the pain sensations without treatment. These measure control for the daily variability in pain, assessment scoring variability, site to site variability and intra subject variability in the "before intervention" state. These variances will be used in the analysis to estimate baseline noise in each measure and measurement uncertainties against which statistical effect will be tested.

Phase 3: Entry. Entry assessments are to determine the entry assessment measures in the untreated case. They are divided into two protocols. All subjects will receive both assessment protocols. Protocol 1 includes the set of self-report measures of pain and sensation. Protocol 2 includes the application of cortical mapping methods using fMRI. The self-report measures of MAP (mapping of phantom pain perception and non-painful phantom sensation) and VAS (Visual Analogue Scale) are included to provide continuous longitudinal application of these instruments throughout the protocol.

Phase 4: Pre-therapy. This phase consists of one visit to set the stimulus ranges for the subject.

Phase 5: Therapy. Treatment will be provided on a daily basis for four (4) weeks. VAS and MAP are administered before and after the therapy to capture immediate transient effects of the therapy.

Phase 6: Outcome. This phase consists of the subjective and objective measures that define the end state of the subject immediately following the course of therapy. These outcomes will be tested against the Entry measures to determine the degree of the effect of the treatment on PLP and sensations. Outcome 1 (N or week 8) is carried out following the last therapy day and Outcome 2 is one week later.

Phase 7: Follow-up. Follow-up is assessed at weeks N+2, N+4 and N+8 (2, 4 and 8 weeks after last therapy day) in all cases. Most sensory feedback treatments have a carry over time course, where the effect carries on beyond the end of treatment. This phase assesses this time course. Subjects will be asked to complete the questionnaires or answer questions asked. Data will be collected through written questionnaires and verbal communication of sensations and pain either in person or over the telephone.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Phantom Limb Pain
Device: Surface Electrical Stimulation
Please see information under 'Detailed description'
Experimental: Surface Electrical Stimulation
Please see information under 'Detailed description'
Intervention: Device: Surface Electrical Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
Same as current
October 2018
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult man or woman >18 yrs and < 75 yrs.
  • Unilateral transradial, transhumeral, transfemoral, or transtibial .
  • Other treatments for PLP tried with poor results.
  • Reading ability is adequate to independently complete study questionnaires.
  • Subject accepts the study protocol as explained by the investigator.
  • No anticipated changes in psychoactive medications over the course of the study; subject agrees to alert study staff if unanticipated medication changes are required during the study.
  • The subject must experience intractable PLP equal to or greater than 6 on Visual Analogue Scale for Pain (VAS; 0-10 analogue scale).
  • 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 phantom pain, is healthy and able to carry out the experiment

Exclusion Criteria:

  • Severe cognitive impairment as indicated by IQ <70
  • Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I, schizophrenia
  • Pregnancy
  • History of or active substance abuse disorder
  • Acquired brain injury with residual impairment that would interfere with participation in the trial
  • Prior neurological or musculoskeletal disease that would interfere with participation in the trial
  • Current or prior dermatological conditions that would interfere with participation in the trial
  • Excessive sensitivity to electrical stimulation with surface electrode.
  • Interfering anxiety about electrical stimulation or pain.
  • Persons with other diseases that may affect the function of the nervous system. (eg, diabetes, HIV, renal failure)
  • Persons with an implantable stimulator such as a pacemaker or any type of metallic shrapnel, object or device.
  • History of claustrophobia, obesity, or other condition that interferes with the fMRI
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02519907
EPIONE-602547-2
602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
No
Not Provided
Not Provided
Ken Yoshida, Indiana University
Indiana University
  • Aalborg University
  • Aalborg Universitetshospital
  • University of Lausanne Hospitals
  • Université Montpellier
  • Lund University
  • Novosense AB
  • Mxm-Obelia
  • Ecole Polytechnique Fédérale de Lausanne
  • Universitat Autonoma de Barcelona
  • Catholic University of the Sacred Heart
Principal Investigator: Ken Yoshida, PhD Indiana University
Indiana University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP