NCT07610850Toboroz
Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 8.
Rövid összefoglaló (regiszter, angolul)
The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with cervical and lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of upper and lower limbs in participants with chronic stroke suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the spinal cord, which should not only improve or restore voluntary control of arm and leg movement and support immediate mobility, but also promote neurological recovery when combined with neurorehabilitation.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 3 (tervezett)
- Első benyújtás
- 2026. ápr. 15.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2028. okt.
- Fő szponzor
- Ecole Polytechnique Fédérale de Lausanne
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07610850
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 3
- 2026. szept. 1. és az elsődleges befejezés (2028. okt.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery.
- Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study.
Más betegség
- Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.
- Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist.
- Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy, etc.).
Egyéb
- Must not be pregnant or breast feeding (if applicable).
- Must not have the intention to become pregnant during the study (if applicable).
- Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support.
- Must not have any active implanted device, such as a pacemaker or other neurostimulator.
- Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale > 3).
- Must not have indication requiring frequent MRIs.
- Must not be the investigator him/herself, his/her family members, employees, and other dependent persons.
Kiket keres a vizsgálat
- Must be between 18-70 years old at the time of enrolment.
- Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.
- Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.
- Must be able to stand with or without assistive device for 30 seconds.
- Must have a score higher than 22 at the Montreal Cognitive Assessment.
- Must present right or left hemiplegia.
- Must have completed primary standard of care rehabilitation.
- Must provide and sign the study's Informed Consent prior to any study-related procedures.
- Must be able to understand and interact with the study team in French or English.
- Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.
- Must use effective contraception for women of childbearing capacity.
- Must be able to withhold antiplatelet/anticoagulation agents perioperatively for the time of the surgeries (if applicable).
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Svájc | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.