Status:
TERMINATED
An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Spinal Cord Injury (SCI) leads to alterations in brain structure and function by spinal nerve damage, secondary inflammatory responses, and by the consequences of living with paralysis and neuropathic...
Detailed Description
This clinical trial will utilize a randomized, controlled, crossover design. Participants will be randomized to (A) 12 weeks of FES-RT followed by 12 weeks of treatment as usual or (B) 12 weeks of tre...
Eligibility Criteria
Inclusion
- \* SCI at or below neurological level C5 with American Spinal Injury Association grade A, B or C, within 3-24 months after injury.
Exclusion
- pregnancy
- breast feeding
- contraindications to MRI
- contraindications to PET current or past history of:
- major medical illness
- major neurological illness other than SCI
- major psychiatric illness
- diabetes
- major kidney or liver problems
- use of tobacco
- use of recreational drugs
- an abnormal physical exam (e.g., heart murmurs or peripheral edema).
- unresponsive to FES stimulation
- heart disease
- physical limitations to FES-RT success
- blood pressure\>140/90 mmHg
- significant arrhythmias
- cancer
- epilepsy
- current use of cardioactive medications
- current grade 2 or greater pressure injuries at relevant contact sites
- peripheral nerve compressions or rotator cuff tears that limit the ability to row
- history of bleeding disorder
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04137159
Start Date
February 20 2020
End Date
November 1 2024
Last Update
January 9 2026
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129