Omurilik Yaralanması ve ALS Olan Bireylerde Uzaktan İskemik Koşullandırmanın El Kullanımı Üzerindeki Etkileri

Sade dilde özet

Bu çalışma, omurilik yaralanması (spinal cord injury) veya amyotrofik lateral skleroz (ALS) olan bireylerde, uzaktan iskemik koşullandırma (remote ischemic conditioning) uygulamasının el kullanımı üzerindeki etkilerini incelemektedir. Çalışmaya, 18-75 yaş arası, ilgili tanıya ve belirli kas fonksiyonu ölçütlerine sahip bireyler ile sağlıklı kişiler katılabilmiştir. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

Bronx VA Medical Center

Müdahale

Active Remote Ischemic Conditioning, Sham Remote Ischemic Conditioning, Isometric hand exercise

Başlangıç

28.10.2019

Tahmini bitiş

31.10.2022

Ülkeler

United States

İlgili genler

Merkezler

• The Bronx, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Able-bodied participants

1. Age between 18 and 75 years;
2. No known central or peripheral neurological disease or injury.

SCI participants

Inclusion Criteria:

1. Age between 18 and 75 years;
2. Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
3. Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
4. Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
5. Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.

ALS participants

1. Age between 21 and 75 years;
2. Diagnosis of probable or definite ALS.
3. Incomplete weakness of left or right wrist or hand muscles: score of 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction.
4. Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
5. Able to perform thumb-middle finger opposition pinch task with detectable APB electromyography (EMG) muscle activity.

Exclusion Criteria:

1. Multiple spinal cord lesions;
2. History of seizures;
3. Use of medications that significantly lower seizure threshold, such as amphetamines and bupropion;
4. History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
5. Any extremity soft tissue, orthopedic, or vascular condition or injury that may contraindicate remote limb ischemic conditioning (RLIC) (uncontrolled hypertension, peripheral vascular disease, hematological disease, severe hepatic or renal dysfunction);
6. Any other contraindication to undergoing magnetic resonance imaging (except for claustrophobia);
7. Clinically significant infection of any kind (urinary tract, pulmonary, skin or other)
8. Significant coronary artery or cardiac conduction disease;
9. Open skin lesions over the neck, shoulders, or arms;
10. Pregnancy
11. Unsuitable for study participation as determined by study physician. In addition, a medical record review will be conducted to identify any other medical concerns that might increase the risks associated with participation.