Phantom Limb Pain Clinical Trial
— EPIONEOfficial title:
Natural Sensory Feedback for Phantom Limb Modulation and Therapy
Verified date | December 2018 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 6 |
Est. completion date | October 2019 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | IU Health Neuroscience Center | Indianapolis | Indiana |
United States | Rehabilitation Hospital of Indiana | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Aalborg Universitetshospital, Aalborg University, Catholic University of the Sacred Heart, Ecole Polytechnique Fédérale de Lausanne, Lund University, Mxm-Obelia, Novosense AB, Universitat Autonoma de Barcelona, Université Montpellier, University of Lausanne Hospitals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phantom limb pain | The pain intensity will be assessed using visual analog scale (VAS) | Change in pain perception from baseline to three months | |
Primary | Cortical reorganization | The cortical response to peripheral stimulation will be tracked using MRI | Change in pain perception from baseline to three months | |
Secondary | Phantom limb pain | The pain symptoms will be assessed using the neuropathic pain symptom inventory (NPSI) | Change in neuropathic pain symptoms from baseline to three months |
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