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De klinische studie NCT07139483 voor Phantom Limb Pain After Amputation is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS 108 Gerandomiseerd Dubbelblind Adaptief ontwerp Innovatief
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De klinische studie NCT07139483 is een interventioneel studie bij Phantom Limb Pain After Amputation met de status rekruterend. Het doel is om 108 deelnemers te includeren vanaf 25 maart 2025. De studie wordt geleid door de Universiteit van Haifa en de voltooiing is gepland op 1 maart 2029. Laatste update op ClinicalTrials.gov: 8 september 2025.
Beknopte samenvatting
Background: Most amputees experience phantom limb pain (PLP), for years after amputation. Virtually all PLP research to date has focused on the mechanisms of chronic PLP, ignoring the mechanisms of chronification. This research project will focus on combined neuromodulatory interventions of mirror therapy (MT) and trans direct-cranial stimulation (tDCS), applied for the first time at the acute state of PLP, with an a...Toon meer
Uitgebreide beschrijving
Approximately 80% of amputees experience PLP, often severe, for years after amputation and most amputees will experience phantom limb sensations, including kinetic, proprioceptive (i.e. feeling of length or volume) and exteroceptive sensations (e.g. touch, pressure, itching). Treatment options for PLP have generally been limited, and there is no clear consensensus on the optimal treatment regimen. In PLP maladaptive ...Toon meer
Officiële titel
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With Transcranial Direct Current Stimulation
Aandoeningen
Phantom Limb Pain After AmputationAndere studie-ID's
- 253/23
NCT-ID
Startdatum (Werkelijk)
2025-03-25
Laatste update geplaatst
2025-09-08
Verwachte einddatum
2029-03
Inschrijving (Geschat)
108
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
PLP
Phantom sensation
telescoping
amputation
tDCS
MT
Maladaptive plasticity
Phantom Limb Pain
Phantom sensation
telescoping
amputation
tDCS
MT
Maladaptive plasticity
Phantom Limb Pain
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorMirror Therapy + real tDCS Both MT and tDCS neuromodulatory interferences (separately or combined) will consist of 20 sessions, each lasting 20 min, completed during 4 weeks, once daily (excluding weekends). The neuromodulatory interferences will be self-administered by the participants. The first 2 sessions (at the clinic) will include training to familiarize participants (and their primary caregivers) with the procedure and to instruct them ...Toon meer | Trans Direct-Cranial Stimulation (tDCS) The tDCS electrodes will be inserted into 5×7 cm (35 cm2) sponges soaked with saline (0.9 M) and placed as follows: anode over the M1 contralateral to the amputated limb (adjusted based on lower/upper amputation), and cathode over the forehead, contralateral to the anode (ipsilateral to amputated limb). Total stimulation duration will be 20 min, with a rise and decline time of 30 sec and stimulus intensity of 1.5 mA ...Toon meer Spiegeltherapie Participants will be seated with a portable mirror between their limbs so that the unaffected limb is reflected in the mirror. The participants will focus their attention on the reflection in the mirror and perform the following movements: plantarflexion and dorsiflexion and inversion and eversion of the foot, flexion and extension of the wrist and ulnar and radial deviation, for lower and upper limp amputates, respe...Toon meer |
SchijncomparatorMirror Therapy + sham tDCS Both MT and tDCS neuromodulatory interferences (separately or combined) will consist of 20 sessions, each lasting 20 min, completed during 4 weeks, once daily (excluding weekends). The sham tDCS will be identical to the real tDCS, except no current will be applied. However, as recommended, during the first and last 30 sec, the current will be ramped up to 1.5 mA and immediately back to 0 to induce scalp sensations si...Toon meer | Trans Direct-Cranial Stimulation (tDCS) The tDCS electrodes will be inserted into 5×7 cm (35 cm2) sponges soaked with saline (0.9 M) and placed as follows: anode over the M1 contralateral to the amputated limb (adjusted based on lower/upper amputation), and cathode over the forehead, contralateral to the anode (ipsilateral to amputated limb). Total stimulation duration will be 20 min, with a rise and decline time of 30 sec and stimulus intensity of 1.5 mA ...Toon meer Spiegeltherapie Participants will be seated with a portable mirror between their limbs so that the unaffected limb is reflected in the mirror. The participants will focus their attention on the reflection in the mirror and perform the following movements: plantarflexion and dorsiflexion and inversion and eversion of the foot, flexion and extension of the wrist and ulnar and radial deviation, for lower and upper limp amputates, respe...Toon meer |
Geen interventieNo-intervention, natural-course group The participants will receive the regular treatment regimen at the rehabilitation center, including physical-therapy and pharmacological treatment, without intervention of Mirror-therapy and tDCS. | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
A 0-100 VAS of mean pain intensity during one week | completed during 7 days, will be used to capture the weekly average of pain intensity (0 = no pain to 100 = the worst imaginable pain, via pain diary). This data will be used either in its raw, continuous form or as a transformed dichotomous variable, yes/no chronic PLP. A cutoff value of PLP intensity ≤20/100 will be used, because from a clinical perspective, pain intensity ≤20 is considered low and will seldom prompt a request for analgesic treatment. | Pain will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Sense of ownership and agency over phantom limb | Sense of ownership and agency over phantom limb will be a behavioral marker for function of the multisensory integration network. It will be evaluated using a self-report questionnaire with demonstrated sensitivity to detect changes after MT. Six of the questionnaire's 8 items (on a 5-point Likert scale) will be used to assess sense of ownership and agency of upper limb and will be adjusted for the lower limb. Mean scores of 3 questions will evaluate the sense of ownership, and 3 others, the sense of agency, as recommended. | Sense of ownership and agency over phantom limb will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
The Hospital Anxiety and Depression Scale (HADS) | The researchers' marker for function of the fronto-striatal-amygdala circuit, will be assessed via the Hospital Anxiety and Depression Scale (HADS), a self-report 14-item questionnaire focusing on nonphysical symptoms, which measures anxiety and depression, both demonstrated associations with changes in fronto-striatal connectivity. The HADS uses a 0-21 scoring scale, with each item rated on a 4-point Likert scale (0-3). A score of 0-7 is considered normal, 8-10 indicates a mild disorder, 11-14 suggests a moderate disorder, and 15-21 points to a severe disorder. | Anxiety and Depression will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
The Short Form McGill Pain Questionnaire | The researchers' marker for function of the fronto-striatal-amygdala circuit, will also be assessed via the Short Form McGill Pain Questionnaire, which assesses various affective qualities of pain and has demonstrated validity in neuropathic populations. Four affective descriptors rated on a 0-10 numerical rating scale will be summarized. | The Affective qualities of pain will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
The Conditioned Pain Modulation (CPM) | Endogenous pain inhibition will be a psychophysical marker for function of the fronto-PAG circuit. It will be evaluated by the conditioned pain modulation (CPM) paradigm, based on the systemic pain-inhibits-pain phenomenon. The conditioning stimulus will be administrated by immersing the palm in a cold-water bath (14°C). The test stimulus applied on the contralateral (to the conditioning stimulus) lower leg will include individually calibrated heat pain stimulus applied for 20 sec, while averaging pain intensity scores on a VAS Scale (0=no pain, 100= the worst imaginable pain) reported at time 0, 10, and 20 sec. CPM is calculated by subtracting pain scores of the test stimulus given alone from those given with the conditioning stimulus, as recommended. | The CPM score will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
Frequency of PLP paroxysms | Frequency of PLP paroxysms, known to be correlated with PLP intensity or to be affected by neuromodulation techniques applied in PLP, will be evaluated daily for 1 week. Paroxysm will be defined as a period when PLP clearly increases above background pain level; frequency will be evaluated by the average value of the daily score on a 0-100 VAS (0="never during the day" to 100="very frequently"). | Frequency of PLP paroxysms will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
Stump pain | Stump pain, known to be correlated with PLP intensity or to be affected by neuromodulation techniques applied in PLP, will be evaluated daily for 1 week. It will be evaluated by the average value of the daily score on a 0-100 VAS (0="not painful at all" to 100="the worst imaginable pain"). | Stump pain will be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
Phantom sensations | Phantom sensations, known to be correlated with PLP intensity or to be affected by neuromodulation techniques applied in PLP, will be evaluated daily for 1 week. It will be evaluated by the average value of the daily score on a 0-100 VAS (0="no sensations" to 100="very intense"). | Phantom sensations be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
Telescoping | Telescoping, known to be correlated with PLP intensity or to be affected by neuromodulation techniques applied in PLP, will be evaluated daily for 1 week. Telescoping will be evaluated by the average value of the daily score on a 0-100 VAS (0="no telescoping sensations" to 100="very intense telescoping sensations"). | Telescoping be compared between baseline and 4 weeks after the end of the 4 weeks intervention (meaning, comparing baseline to timepoint number 3, which is exactly 8 weeks from the end of the baseline week) |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Adults (age ≥18);
- Amputation of a single limb ≤12 weeks ago; during this period of time, 80% of amputees develop PLP. Both upper and lower limb amputees are included to increase feasibility;
- Acute PLP stage (2 weeks since first report), with intensity ≥3 on a 0-10 VAS;
- No change in medication in past week, excluding pro re nata analgesics;
- Can understand the study's purpose and instructions;
- Agrees to participate and to provide written informed consent.
- Stump wound not healed;
- Other psychological, psychiatric, or neurological conditions;
- Contraindications for tDCS or magnetic resonance imaging (MRI) (MRI data will not be analyzed in the proposed PhD project), including previous seizure, loss of consciousness due to head injury, metal in the head, implanted devices, claustrophobia, a skin condition or an unhealed wound on the scalp, and possibility of being pregnant;
- Inability to provide informed consent or understand or carry out the experiment.
- 🏥Loewenstein Ho...
Centraal Contactpersoon
Contact: Roi Treister, PhD, +972533839935, [email protected]
Contact: Shlomit Sorek, BPT MPT, +972-0507324111, [email protected]
3 Studielocaties in 1 landen
Israel
Loewenstein Hospital, Raanana, Israel, Ahuza 278, Israel
Hadara Minster-Segev, Ms., Contact, +97250-8428855, [email protected]
Nitza Segal, NP, Hoofdonderzoeker
Rekruterend
Reut Medical Center, Tel Aviv, Israel, Israel
Zoya Katzir, Ms., Contact, +972-5486921, [email protected]
Simon Levi, MD, Hoofdonderzoeker
Rekruterend
Sheba Medical Center, Tel Aviv, Israel
Nofar Fuorman, Contact, 0544764884, [email protected]
Oren Barzel, MD, Hoofdonderzoeker
Nog niet rekruterend