NCT05589402Befejeződött1. fázis
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 31.
Rövid összefoglaló (regiszter, angolul)
The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 52 (tényleges)
- Első benyújtás
- 2022. jún. 23.
- Kezdés
- 2019. jún. 4.
- Elsődleges befejezés
- 2026. júl. 15.
- Fő szponzor
- University of Texas Rio Grande Valley
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT05589402
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 52
- 2019. jún. 4. és az elsődleges befejezés (2026. júl. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Current participation in upper limb rehabilitation therapies
- Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months
- Current use of illicit drugs (including heroin, crack/cocaine, marijuana), abusing alcohol or having withdrawn from alcohol in the last 6 months
Más betegség
- History of seizures
- First-degree relative with medication-resistant epilepsy
- Other neurological impairment or condition
- History of traumatic brain injury as documented by Rancho Scale Impairment of <5
- History of brain MRI documented focal cerebral cortex infarct (e.g. hydrocephalus)
- Allergic to lidocaine
- A neuroactive medication that has the potential to lower the seizure threshold
- Based on documented publications in stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics
- All medications will be reviewed with physician, Dr. Amol Utturkar (DHR)
- Healthy Controls:
- History of seizures
- First-degree relative with medication-resistant epilepsy
- Allergy to lidocaine
- Other neurological impairment or condition
- A neuroactive medication that has the potential to lower the seizure threshold
- Based on documented publications on stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics
Egyéb
- SCI Patients:
- Pacemaker or another implanted device
- Metal in the skull
- Pregnancy
- Pressure ulcers
- Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity <50 m/s
- Contractures at the elbow
- Severe spasticity as noted by a modified ashworth scale (MAS) > 4
- Documented, non-sedated post-traumatic amnesia lasting more than 48 hours
- Pregnancy
- Pacemaker or other implanted device
- Metal in the skull
- Pregnancy
Kiket keres a vizsgálat
- SCI Patients:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 and 75 years old
- Have physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)
- Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D
- iSCI occurred at least 18 months ago
- Level of injury or lesion is between C2 and T1
- Bicep strength must be classified as ≥ 3 muscle grade as defined by the medical research council scale
- Tricep strength must be at least an MRC grade of 2 and bet at least 1 muscle grade lower than the bicep
- Both the biceps and triceps will be required to elicit an active motor evoked potential >200 uV with transcranial magnetic stimulation
- Must maintain current medication regime
- Must present with a weaker side of the body, as indicated by a Upper extremity motor score difference between the left and right side
- UEMS < 40 (50 max score)
- Must be able to perform reaching movement training task
- Healthy Controls:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 and 75 years old
- Must be right-handed
- Must be able to perform hand exercises
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Texas Rio Grande Valley | Harlingen | Egyesült Államok | Ismeretlen állapot |
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