임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07139483은(는) Phantom Limb Pain After Amputation에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS 108 무작위 배정 이중 눈가림 적응형 설계 신규 요법
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07139483은(는) Phantom Limb Pain After Amputation에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 3월 25일에 시작되어 108명의 참여자를 모집하고 있습니다. 하이파 대학교이(가) 진행하며, 2029년 3월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 8일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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 ...더 보기
공식 제목
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With Transcranial Direct Current Stimulation
질환명
Phantom Limb Pain After Amputation기타 연구 식별자
- 253/23
NCT 번호
실제 연구 시작일
2025-03-25
최신 업데이트 게시
2025-09-08
예상 연구 완료일
2029-03
계획된 등록 인원
108
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
PLP
Phantom sensation
telescoping
amputation
tDCS
MT
Maladaptive plasticity
Phantom Limb Pain
Phantom sensation
telescoping
amputation
tDCS
MT
Maladaptive plasticity
Phantom Limb Pain
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군Mirror 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 ...더 보기 | 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 ...더 보기 거울 치료 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...더 보기 |
거짓 대조군Mirror 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...더 보기 | 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 ...더 보기 거울 치료 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...더 보기 |
비개입No-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. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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...
연구 대표 연락처
연락처: Roi Treister, PhD, +972533839935, [email protected]
연락처: Shlomit Sorek, BPT MPT, +972-0507324111, [email protected]
3 1개국에 임상시험 장소
Israel
Loewenstein Hospital, Raanana, Israel, Ahuza 278, Israel
Hadara Minster-Segev, Ms., 연락처, +97250-8428855, [email protected]
Nitza Segal, NP, 책임연구자
모집중
Reut Medical Center, Tel Aviv, Israel, Israel
Zoya Katzir, Ms., 연락처, +972-5486921, [email protected]
Simon Levi, MD, 책임연구자
모집중
Sheba Medical Center, Tel Aviv, Israel
Nofar Fuorman, 연락처, 0544764884, [email protected]
Oren Barzel, MD, 책임연구자
대상자모집전