Magnetic Mitohormesis (MM) Treatment in Stroke Rehabilitation. (QTX-001)
Although sarcopenia is commonly seen in stroke patients with a prevalence rate of 42%, relevant research studies are more in geriatric population rather than in stroke patients. Beside conventional functional physiotherapy, improving blood circulation, improving cellular oxygenation and reducing inflammation by MM therapy is supposed to improve muscle atrophy after stroke, thus enhancing the functional recovery.
The investigators are not investigating the direct effect of MM therapy on muscle mass in the current study, but are looking at the function outcomes and changes in quality of life of patients after MM therapy, which is more relevant to the clinical practice in stroke recovery.
Based on literature review and previous studies, stroke patients might benefit from MM therapy by enhancing the outcomes in functional mobility and measures of quality of life, so the purpose of this study is to investigate if MM treatment could boost the functional recovery and muscle strength on top of the effects from the conventional physiotherapy.
The findings of this study might improve the medical knowledge on how MM therapy could affect clinical function outcome in post-stroke rehabilitation and provide alternative method to enhance motor recovery.
연구 개요
상세 설명
In this clinical trial, participants will be exposed to MM fields for 10 minutes per week for a maximum of 12 weeks in addition to standard clinical follow-up.
The route of administration, dosage, and frequency are based on studies done in vitro and in vivo models in mice and in adults. At the Swiss Federal Institute of Technology (ETH) in Zurich, the inventors of the MM device were contracted by the Swiss Agency (Bundesamt für Gesundheit, BAG) to test for the safety of diverse PEMF-delivery devices. The MM device was shown to be non-cytotoxic and non-transforming and produces pulsed magnetic fields at flux densities up to 2 mT peak and consists of a privately designed control unit and coil system. For clinical purposes the MM device will be working at less than this value (1.5 mT). Previous data showed enhancement in muscle with only 10 minutes of non-invasive MM fields exposure per week in mice.
In previous human trials, on healthy individuals following ACL-reconstructive surgery, exposure to MM fields showed muscle metabolic improvement and reduced muscle breakdown (measured effects of MM on serum ceramides, lysophosphatidylcholine, TNNT1 and P3NP), myokine upregulation reflecting improved muscle regeneration (measured effects of MM on Follistatin, IGF1, FGF21, IL-6). This was in response to two 10 minutes MM exposures per week on the operated leg. These findings helped to set up the treatment regime for the MM device to impose myogenic effects, including exposure time per session, number of treatment sessions and duration of treatment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 159053
- Stroke Support Station (S3) - Enabling Village
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Singapore
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Singapore, Singapore, 싱가포르, 648886
- Stroke Support Station (S3) - Jurong Point
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult age 30 - 70 years
- Diagnosis of stroke(s), with most recent stroke at least 10 weeks prior to study participation
- Functional Ambulation Categories (FAC): 2 to 3
- Normal cognition with Montreal Cognitive Assessment (MOCA) score 21
- Intact language skills to comprehend and follow directions as per Investigator's assessment.
- Individuals must agree to comply with all study visits and procedures.
- Individuals must freely provide consent to study participation.
Exclusion Criteria:
- Contraindications to PEMF therapy, which include electronic implants (e.g., pacemaker, implantable cardioverter defibrillator, cochlear implants)
- History of neurological disorder (e.g Seizure, Myasthenia Gravis, Multiple Sclerosis and Myopathies) other than stroke
- Pregnant and lactating women
- Simultaneously receiving standard care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: Sham group
control group receiving the placebo |
Sham sessions help to maintain participant blinding while eliminating the therapeutic electromagnetic field exposure. The sham device mode reproduces the visual and auditory characteristics of active MM treatment, including display screens, indicator lights, operational sounds, and treatment duration timer. However, no therapeutic electromagnetic field is generated. MM devices can be configured to deliver either active treatment or sham treatment through the use of an RFID card reader. RFID cards are pre-programmed and randomised to correspond to either an active or sham session. When the assigned RFID card is tapped on the device, the corresponding treatment protocol is automatically initiated. Therefore double-blinding of both participants and study team / operators / assessors is possible |
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활성 비교기: Treated Group
Intervention group receiving MM therapy |
The intervention will be held at the stipulated study sites. Participants in the intervention group will be exposed to active pulse electromagnetic field treatment by a tested device. The active pulse electromagnetic field device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Safety - Safety profile and Number of participants with treatment-related AEs and SAEs
기간: 16 weeks
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To assess safety of MM in subacute stroke patients with moderately affected mobility for functional mobility training, assessed through number of participants with treatment-related adverse events, and safety evaluation of the adverse event (AE) profiles. |
16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mobility - 10-Metre Walk Test
기간: From baseline to 16 weeks
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Gait speed assessed by 10-Metre Walk Test, administered by physiotherapist. |
From baseline to 16 weeks
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Mobility - 5 Times Sit To Stand Test
기간: From baseline to 16 weeks
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Lower limb strength assessed through the 5TSTS administered by a physiotherapist. |
From baseline to 16 weeks
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Mobility - Timed Up and Go
기간: From baseline to 16 weeks
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Dynamic balance assessed through the TUG administered by a physiotherapist. |
From baseline to 16 weeks
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Quality of Life - EuroQoL-5D-5L
기간: From baseline to 16 weeks
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EQ-5D-5L is an established tool for assessing the general health status of individuals across a wide array of health conditions and treatments. It measures health outcomes in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale, from no problems (level 1) to extreme problems (level 5), facilitating a comprehensive evaluation of a patient's health-related quality of life. The total score is derived by converting the individual dimension scores into a single summary index value, reflecting the overall health status, with higher scores indicating better health outcomes. |
From baseline to 16 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gobinathan Chandran, National University Hospital, Singapore
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- QuantumTX
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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