Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain
NCT ID: NCT04071275
Last Updated: 2019-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-04-22
2019-11-30
Brief Summary
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Detailed Description
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Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
It was hypothesize that combination of mirror therapy and tDCS treatment could result in additive effects. According to this hypothesis, the effects of the mirror therapy could be enhanced by the tDCS treatment. The aim of the current study is to investigate this hypothesis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mirror therapy
Subjects will be asked to perform specific movements (using the unaffected limb while watching its mirrored reflection for 20 minutes per day, for 10 treatment days, completed during two weeks (every weekday, excluding weekends)
Mirror therapy
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
Mirror therapy + sham tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, a sham tDCS treatment will be applied.
transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
Mirror therapy
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
Mirror therapy + active tDCS
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, an active tDCS treatment will be applied.
transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
Mirror therapy
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
Interventions
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transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
Mirror therapy
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
Eligibility Criteria
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Inclusion Criteria
2. Underwent unilateral lower limb amputation in the past 3 months. A
3. Reported average phantom pain of 4 or more in the past week.
4. No change in other medications 1 week prior to enrollment, not including SOS.
5. Able understand the purpose of the study and to provide informed consent.
Exclusion Criteria
1. Epilepsy or prior seizures within the last 1 year.
2. Suffering from severe depression
3. History of unexplained fainting or loss of consciousness
18 Years
ALL
No
Sponsors
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Loewenstein Hospital
OTHER
Responsible Party
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Hagay Amir
Medical Diractor
Principal Investigators
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Nitza Segal, M.A
Role: STUDY_CHAIR
Leowenstein Hospital
Locations
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Loewenstein Hospital
Raanana, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MOH_3107-2018-003552
Identifier Type: -
Identifier Source: org_study_id
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