An interventional study of Therapy with and without spinal cord stimulation in Spinal Cord Injuries, sponsored by NHS Greater Glasgow and Clyde. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
The purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 12 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function.
Other: Therapy with and without spinal cord stimulation
Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.
Acceptance
Whether the treatment protocol is acceptable by people with complete tetraplegia. This will be assessed using semi structured interview results of which will be analysed qualitatively to determine the number of participants who would use the therapy on an ongoing basis.
Time frame: 26 weeks at the end of intervention
Clinical effectiveness of spinal cord stimulation using GRASSP tool
Effectiveness of spinal cord stimulation in inducing changes in functional outcome. This will be assessed using the Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP tool). The unit is based on the GRASSP measurement scale.
Time frame: 26 and 38 weeks, at the end of intervention and at follow up respectively
Neurophysiological change
Effectiveness of spinal cord stimulation in inducing changes in Neurophysiological equivalence of volitional movement. This will be assessed using changes in amplitude in mV of transcranial magnetic stimulation.
Time frame: 26 and 38 weeks, at the end of intervention and at follow up respectively
Sensation
Change in sensation due to the intervention. This will be assessed using change the sensory score of the International Standards for Neurological classification of SCI (ISNCSCI)
Time frame: 26 weeks at the end of intervention
Spasticity
Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
Time frame: 26 weeks at the end of intervention
Autonomic function
Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set.
Time frame: 26 weeks at the end of intervention
Change in perceived health status
The effect of the study on perceived health status of the participants will be assessed using QUALITY OF LIFE BASIC DATA SET of the International Spinal Cord Injury Data Set.
Time frame: 26 weeks at the end of intervention
No study locations are listed for this record.
Plan to share: Undecided — The is no plan yet to share individual participant data.
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde