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Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS 108 Aleatorizado Doble ciego Diseño adaptativo Novedoso

Reclutando
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El ensayo clínico NCT07139483 es un estudio intervencionista para Phantom Limb Pain After Amputation. Su estado actual es: reclutando. El estudio se inició el 25 de marzo de 2025, con el objetivo de reclutar a 108 participantes. Dirigido por la Universidad de Haifa, se espera que finalice el 1 de marzo de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 8 de septiembre de 2025.
Resumen
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...Mostrar más
Descripción detallada
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 ...Mostrar más
Título oficial

Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With Transcranial Direct Current Stimulation

Condiciones médicas
Phantom Limb Pain After Amputation
Otros ID del estudio
  • 253/23
Número del NCT
Inicio del estudio (real)
2025-03-25
Última actualización
2025-09-08
Fecha de finalización (estimada)
2029-03
Inscripción (prevista)
108
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
PLP
Phantom sensation
telescoping
amputation
tDCS
MT
Maladaptive plasticity
Phantom Limb Pain
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activoMirror 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 ...Mostrar más
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 ...Mostrar más
Terapia de espejo
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...Mostrar más
Comparador simuladoMirror 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...Mostrar más
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 ...Mostrar más
Terapia de espejo
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...Mostrar más
Sin intervenciónNo-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/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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...
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Contactos centrales del estudio
Contacto: Roi Treister, PhD, +972533839935, [email protected]
Contacto: Shlomit Sorek, BPT MPT, +972-0507324111, [email protected]
3 Centros del estudio en 1 países

Israel

Loewenstein Hospital, Raanana, Israel, Ahuza 278, Israel
Hadara Minster-Segev, Ms., Contacto, +97250-8428855, [email protected]
Nitza Segal, NP, Investigador principal
Reclutando
Reut Medical Center, Tel Aviv, Israel, Israel
Zoya Katzir, Ms., Contacto, +972-5486921, [email protected]
Simon Levi, MD, Investigador principal
Reclutando
Sheba Medical Center, Tel Aviv, Israel
Nofar Fuorman, Contacto, 0544764884, [email protected]
Oren Barzel, MD, Investigador principal
Aún no recluta