Surface Electrical Stimulation for Treatment of Phantom Limb Pain
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/13/2018 |
| Start Date: | September 2015 |
| End Date: | October 2019 |
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.
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.
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.
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
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