Last updated: November 17, 2020
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting
Phase
N/A
Condition
Spinal Cord Injuries
Cerebral Ischemia
Stroke
Treatment
N/AClinical Study ID
NCT04641793
STU00210086
Ages 16-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
- Uninjured individuals Inclusion criteria:
- Ages 18 and up.
- Ability to follow simple commands, and to respond to questions. Exclusion criteria for SCI participants: • Does not meet the inclusion criteria.
- Individuals with SCI Inclusion criteria:
- Age 16-65
- Injuries at the C3-6 level, complete (ASIA A), or incomplete (ASIA B and C).
- Able to follow simple commands
- Able to speak or respond to questions
Exclusion
Exclusion criteria:
- Presence of tremors, spasm and other significant involuntary movements
- Cognitive impairment
- Deficit of visuo-spatial orientation
- Concurrent pressure sores or urinary tract infection
- Other uncontrolled infection, concurrent cardiovascular disease
- Sitting tolerance less than one hour
- Severe hearing or visual deficiency
- Miss more than six appointments without notification
- Unable to comply with any of the procedures in the protocol
- Unable to provide informed consent
- Stroke survivors: Inclusion criteria:
- Recent stroke (Sub acute to early chronic, between 3 and 12 months from CVA)
- Age less than 75 (To avoid age-related confounds)
- Inability to operate a manual wheelchair
- Available medical records and radiographic information about lesion locations
- Significant level of hemiparesis (UE Fugl Meyer score between 10 and 30)
- Presence of pathological muscle synergies in the UE (flexor and/or extensor synergy) Exclusion criteria:
- Aphasia, apraxia, cognitive impairment or affective dysfunction that would influencethe ability to perform the experiment
- Inability to provide informed consent
- Severe spasticity, contracture, shoulder subluxation, or UE pain
- Severe current medical problems, including rheumatoid arthritis or other orthopaedicimpairments restricting finger or wrist movement Additional exclusion criteria for participants enrolled in TMS procedures
- Any metal in head with the exception of dental work or any ferromagnetic metalelsewhere in the body. This applies to all metallic hardware such as cochlearimplants, or an Internal Pulse Generator or medication pumps, implanted brainelectrodes, and peacemaker.
- Personal history of epilepsy (untreated with one or a few past episodes), or treatedpatients
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, evenwithout history of seizure, and without anticonvulsant medication
- Administration of drugs that potentially lower seizure threshold [REF], withoutconcomitant administration of anticonvulsant drugs which potentially protect againstseizures occurrence
- Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta,Gabapentin, Naprosyn, Diclofenac, Diazepam, Tramadol, etc) within 2 weeks of any studyvisit.
- Skull fractures, skull deficits or concussion within the last 6 months
- unexplained recurring headaches
- Sleep deprivation, alcoholism
- Claustrophobia precluding MRI
- Pregnancy
Study Design
Total Participants: 60
Study Start date:
January 20, 2020
Estimated Completion Date:
August 31, 2024
Study Description
Connect with a study center
Shirley Ryan Ability Lab
Chicago, Illinois 60611
United StatesActive - Recruiting
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