Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)
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|ClinicalTrials.gov Identifier: NCT05522920|
Recruitment Status : Not yet recruiting
First Posted : August 31, 2022
Last Update Posted : August 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: Therapy with and without spinal cord stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive study intervention|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury|
|Estimated Study Start Date :||August 2022|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||December 2024|
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 [ Time Frame: 26 weeks at the end of intervention ]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.
- Clinical effectiveness of spinal cord stimulation using GRASSP tool [ Time Frame: 26 and 38 weeks, at the end of intervention and at follow up respectively ]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.
- Neurophysiological change [ Time Frame: 26 and 38 weeks, at the end of intervention and at follow up respectively ]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.
- Sensation [ Time Frame: 26 weeks at the end of intervention ]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)
- Spasticity [ Time Frame: 26 weeks at the end of intervention ]Changes in upper limb muscle tone using change in the Modified Ashworth Scale.
- Autonomic function [ Time Frame: 26 weeks at the end of intervention ]Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set.
- Change in perceived health status [ Time Frame: 26 weeks at the end of intervention ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05522920
|Contact: Mariel Purcell, Consultant||+44 141 201 email@example.com|
|Contact: Bethel C Osuagwu, PhD||+44 firstname.lastname@example.org|
|Study Director:||Mariel Purcell, Consultant||NHS Greater Glasgow and Clyde|