Trial Outcomes & Findings for Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury (NCT NCT02037620)

Results Overview

Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

20 months

Results posted on

2022-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Stimulation 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Stimulation n=4 Participants 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 20 months

Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure.

Outcome measures

Outcome measures
Measure	Epidural Stimulation n=4 Participants 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator
Mean Arterial Blood Pressure in Response to Epidural Stimulation	112.5 mmHg Standard Deviation 8.25

Adverse Events

Epidural Stimulation

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epidural Stimulation n=5 participants at risk 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator \*Each participant received all of the interventions. Thus, adverse events cannot be reported for each independent intervention.
Surgical and medical procedures Incision Dehiscence	60.0% 3/5 • Number of events 3 • 12 months
Renal and urinary disorders Urinary Tract Infection	20.0% 1/5 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	Epidural Stimulation n=5 participants at risk 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. 5-6-5 Specify electrode Restore Advance Pulse Generator \*Each participant received all of the interventions. Thus, adverse events cannot be reported for each independent intervention.
Musculoskeletal and connective tissue disorders Right Knee Fracture	20.0% 1/5 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Shoulder Bursitis	20.0% 1/5 • Number of events 1 • 12 months

Additional Information

Dr. Susan Harkema

University of Louisville

Phone: 502-581-8675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place