Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

Spinal Cord Injuries Clinical Trial

Official title:

Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455137
• Other study ID #: IRB112-067-A
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Buddhist Tzu Chi General Hospital
• Contact: Sheng-Tzung Tsai, M.D., Ph.D.
• Phone: +886-3-856-1825
• Email: flydream.tsai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Description:

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• SCI ASIA: A, B, C,D

• Between 20 and 70 year of age

• >1 year post SCI

• Complete or incomplete spinal cord injury.

• Expected will undergo spinal cord stimulation surgery.

• Continued rehabilitation after surgery for spinal cord injury.

• Able to comply with procedures and follow up.

• Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities

Exclusion Criteria:

• Have significant cognitive impairment (MMSE<24).

• Had a mental illness within one year or been treated in the past.

• Have Major depressive disorder.

• Active cancer diagnosis.

• Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.

• Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.

• Unable to read and/or comprehend the consent form.

• Have concerns about this trial and do not sign consent.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Epidural Stimulator
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalography and Electromyography	To measure activity in the brain	To measure assessing change between pre-implant and every 3 months until 24 months.
Primary	Electromyographic analysis	Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest	To measure assessing change between pre-implant and every 3 months until 24 months.
Primary	Single transcranial magnetic stimulation	To evaluate the function of corticospinal tract nerve conduction	To measure assessing change between pre-implant and every 3 months until 24 months.
Primary	Motion Analysis	To evaluate the angles that can be achieved at each joint of the upper limbs	To measure assessing change between pre-implant and every 3 months until 24 months.
Primary	Functional Test	To evaluate gait for subjects who can walk by assistive device or independently	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	American Spinal Injury Association (ASIA-2019) Impairment Scale	To measure and record disease history	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Modified Ashworth scale	To measure the increase of muscle tone	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Barthel Index	To measure performance in activities of daily living	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	World Health Organization Quality of Life Brief Version	A brief version scale of World Health Organization Quality-of-Life scale	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Spinal Cord Independence Measure	To measure performance in activities of daily living and mobility	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Box and Block Test	To measure unilateral gross manual dexterity.	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Action Research Arm Test Scoring Sheet	To measures upper limb function by scoring the ability to complete functional tasks.	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Berg Balance Scale	To measure balance and the risk of falls	To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary	Walking Index for Spinal Cord Injury II (WISCI II- March 2005)	To measure walking ability for spinal cord injury.	To measure assessing change between pre-implant and every 3 months until 24 months.