Trial Outcomes & Findings for Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS (NCT NCT03851302)

Last Updated: 2025-11-10

Results Overview

Response to electrical and magnetic stimulation will be measured via peak-to-peak amplitude (millivolts) in abductor pollicis brevis muscle. Percent change of the electromyographic responses was measured immediately after active/sham RIC plus isometric hand exercise in comparison with baseline measurement. The RIC plus hand exercise duration is 60 minutes.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Outcome measured immediately after completion of RIC plus isometric hand exercise. The RIC plus hand exercise duration is 60 minutes.

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Able Bodied: Active First Visit, Sham Second Visit Subjects without spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS). Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Spinal Cord Injury: Active First Visit, Sham Second Visit Participants with spinal cord injury. Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Spinal Cord Injury: Sham First Visit, Active Second Visit Participants with spinal cord injury. Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).	Amyotrophic Lateral Sclerosis: Active First Visit, Sham Second Visit Participants with amyotrophic lateral sclerosis. Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Able Bodied: Sham First Visit, Active Second Visit Subjects without spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS). Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).
Screening (1 Day) STARTED	5	4	5	3	4
Screening (1 Day) COMPLETED	5	3	3	3	4
Screening (1 Day) NOT COMPLETED	0	1	2	0	0
First Intervention (1 Day) STARTED	5	3	3	3	4
First Intervention (1 Day) COMPLETED	5	3	3	3	3
First Intervention (1 Day) NOT COMPLETED	0	0	0	0	1
Washout (at Least 2 Weeks) STARTED	5	3	3	3	3
Washout (at Least 2 Weeks) COMPLETED	5	3	3	3	3
Washout (at Least 2 Weeks) NOT COMPLETED	0	0	0	0	0
Second Intervention (1 Day) STARTED	5	3	3	3	3
Second Intervention (1 Day) COMPLETED	5	3	3	3	3
Second Intervention (1 Day) NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Spinal Cord Injury: Active First Visit, Sham Second Visit Participants with spinal cord injury. Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Spinal Cord Injury: Sham First Visit, Active Second Visit Participants with spinal cord injury. Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).	Able Bodied: Sham First Visit, Active Second Visit Subjects without spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS). Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).
Screening (1 Day) Withdrawal by Subject	0	1	0
Screening (1 Day) Screened out	1	1	0
First Intervention (1 Day) Withdrawal by Subject	0	0	1

Baseline Characteristics

Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Able Bodied: Sham First Visit, Active Second Visit n=4 Participants Subjects without spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS). Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).	Able Bodied: Active First Visit, Sham Second Visit n=5 Participants Subjects without spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS). Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Spinal Cord Injury: Active First Visit, Sham Second Visit n=3 Participants Participants with spinal cord injury. Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Spinal Cord Injury: Sham First Visit, Active Second Visit n=3 Participants Participants with spinal cord injury. Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).	Amyotrophic Lateral Sclerosis: Active First Visit, Sham Second Visit n=3 Participants Participants with amyotrophic lateral sclerosis. Active first visit (1 day). Washout (2 weeks). Sham second visit (1 day).	Amyotrophic Lateral Sclerosis: Sham First Visit, Active Second Visit Participants with amyotrophic lateral sclerosis. Sham first visit (1 day). Washout (2 weeks). Active second visit (1 day).	Total n=18 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 15.3 • n=5 Participants	31.4 years STANDARD_DEVIATION 7.8 • n=20 Participants	49.3 years STANDARD_DEVIATION 22.5 • n=40 Participants	44.3 years STANDARD_DEVIATION 15.3 • n=28 Participants	44.7 years STANDARD_DEVIATION 20.8 • n=46 Participants	—	43.9 years STANDARD_DEVIATION 15.8 • n=22 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	—	4 Participants n=22 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=20 Participants	3 Participants n=40 Participants	3 Participants n=28 Participants	3 Participants n=46 Participants	—	14 Participants n=22 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	1 Participants n=46 Participants	0 Participants n=34 Participants	3 Participants n=22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=20 Participants	3 Participants n=40 Participants	3 Participants n=28 Participants	2 Participants n=46 Participants	0 Participants n=34 Participants	15 Participants n=22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	0 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	1 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	1 Participants n=46 Participants	0 Participants n=34 Participants	4 Participants n=22 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=20 Participants	3 Participants n=40 Participants	3 Participants n=28 Participants	2 Participants n=46 Participants	0 Participants n=34 Participants	13 Participants n=22 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	0 Participants n=34 Participants	0 Participants n=22 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=20 Participants	3 participants n=40 Participants	3 participants n=28 Participants	3 participants n=46 Participants	—	18 participants n=22 Participants

PRIMARY outcome

Timeframe: Outcome measured immediately after completion of RIC plus isometric hand exercise. The RIC plus hand exercise duration is 60 minutes.

Population: One AB participant withdrew during the first study visit. One ALS participant had no valid data during the first study visit and then withdrew.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=8 Participants Active intervention	SCI-Sham n=6 Participants Spinal cord injured-sham intervention	SCI-Active n=6 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=2 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=8 Participants Sham intervention
Percent Change of Electromyographic Responses After Remote Ischemic Conditioning (RIC) Plus Hand Isometric Exercise	22.2 change (%) from baseline Standard Deviation 46.2	-19.2 change (%) from baseline Standard Deviation 40.1	79.7 change (%) from baseline Standard Deviation 120.4	-6.1 change (%) from baseline Standard Deviation 10.2	111.8 change (%) from baseline Standard Deviation 99.0	17.4 change (%) from baseline Standard Deviation 57.6

SECONDARY outcome

Timeframe: Outcome measured immediately after completion of RIC. The RIC duration is 50 minutes.

Population: One AB participant withdrew during the first study visit. One ALS participant had no valid data during the first study visit and then withdrew.

Response to electrical and magnetic stimulation was measured via peak-to-peak amplitude (millivolts) in abductor pollicis brevis muscle. Percent change of the electromyographic response was measured immediately after active/sham RIC but before isometric hand exercise in comparison with baseline measurement. The RIC duration is 50 minutes.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=8 Participants Active intervention	SCI-Sham n=6 Participants Spinal cord injured-sham intervention	SCI-Active n=6 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=2 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=8 Participants Sham intervention
Percent Change of Electromyographic Responses After RIC But Before Hand Isometric Exercise	21.6 change (%) from baseline Standard Deviation 89.7	-14.8 change (%) from baseline Standard Deviation 41.2	59.9 change (%) from baseline Standard Deviation 127.2	52.3 change (%) from baseline Standard Deviation 56.3	200.1 change (%) from baseline Standard Deviation 289.8	23.5 change (%) from baseline Standard Deviation 60.1

SECONDARY outcome

Timeframe: Outcome measured 15 minutes after completion of RIC plus isometric hand exercise. The RIC plus hand exercise duration is 60 minutes. Therefore this is 75 minutes post baseline.

Population: One AB participant withdrew during the first study visit. One ALS participant had no valid data during the first study visit and then withdrew.

Response to electrical and magnetic stimulation was measured via peak-to-peak amplitude (millivolts) in abductor pollicis brevis muscle. Percent change of the electromyographic responses was measured 15 mins after active/sham RIC plus isometric hand exercise in comparison with the measurement immediately after active/sham RIC plus isometric hand exercise. The RIC plus hand exercise duration is 60 minutes. Therefore this is 75 minutes post baseline.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=8 Participants Active intervention	SCI-Sham n=6 Participants Spinal cord injured-sham intervention	SCI-Active n=6 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=2 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=8 Participants Sham intervention
Percent Change of Electromyographic Responses 15 Mins After RIC Plus Hand Isometric Exercise	35.4 change (%) from baseline Standard Deviation 107.5	-5.1 change (%) from baseline Standard Deviation 36.5	204.9 change (%) from baseline Standard Deviation 291.5	-46.7 change (%) from baseline Standard Deviation 52.6	-6.7 change (%) from baseline Standard Deviation 63.3	15.2 change (%) from baseline Standard Deviation 78.9

SECONDARY outcome

Timeframe: Mean arterial pressure at baseline and immediately after intervention on the same day. RIC plus hand exercise duration is 60 minutes.

Population: Pre-post data was not collected for other visits.

The change in mean arterial pressure will be monitored to ensure the stable hemodynamic responses toward the ischemic stimulation.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=8 Participants Active intervention	SCI-Sham n=3 Participants Spinal cord injured-sham intervention	SCI-Active n=4 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=3 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=8 Participants Sham intervention
Blood Pressure	4.4 change (mm Hg) from baseline Standard Deviation 4.1	8.3 change (mm Hg) from baseline Standard Deviation 14.6	3.4 change (mm Hg) from baseline Standard Deviation 4.9	-5.2 change (mm Hg) from baseline Standard Deviation 5.4	-3.4 change (mm Hg) from baseline Standard Deviation 14.7	1.8 change (mm Hg) from baseline Standard Deviation 4.4

SECONDARY outcome

Timeframe: Heart rate at baseline and immediately after intervention on the same day. RIC plus hand exercise duration is 60 minutes.

Population: Pre-post data was not collected for other visits.

The heart rate will be monitored to ensure the stable hemodynamic responses toward the ischemic stimulation.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=8 Participants Active intervention	SCI-Sham n=2 Participants Spinal cord injured-sham intervention	SCI-Active n=4 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=3 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=8 Participants Sham intervention
Heart Rate	-4.4 change (beats per minute) from baseline Standard Deviation 5.7	-5.0 change (beats per minute) from baseline Standard Deviation 0.7	1.5 change (beats per minute) from baseline Standard Deviation 10.1	-6.0 change (beats per minute) from baseline Standard Deviation 2.8	-3.2 change (beats per minute) from baseline Standard Deviation 3.8	-0.8 change (beats per minute) from baseline Standard Deviation 5.1

SECONDARY outcome

Timeframe: Pulse oximetry at baseline and immediately after intervention on the same day. RIC plus hand exercise duration is 60 minutes.

Population: Pre-post data was not collected for other visits.

The pulse oximetry satuation will be monitored to ensure the stable respiratory responses toward the ischemic stimulation.

Outcome measures

Outcome measures
Measure	Able Bodied-active n=7 Participants Active intervention	SCI-Sham n=2 Participants Spinal cord injured-sham intervention	SCI-Active n=4 Participants Spinal cord injured-active intervention	ALS-sham n=2 Participants Amyotrophic lateral sclerosis - sham intervention.	ALS - Active n=3 Participants Amyotrophic lateral sclerosis - active intervention.	Able Bodied-Sham n=7 Participants Sham intervention
Oxygen Saturation	0.6 change (% saturation) from baseline Standard Deviation 1.4	1.3 change (% saturation) from baseline Standard Deviation 0.4	0.3 change (% saturation) from baseline Standard Deviation 1.3	0 change (% saturation) from baseline Standard Deviation 1.4	2.3 change (% saturation) from baseline Standard Deviation 2.1	0.4 change (% saturation) from baseline Standard Deviation 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in mediator level between baseline measurement and immediately after completion of RIC. RIC duration is 50 minutes.

The blood samples will be collected before and after RIC to analyze on the changes of inflammatory mediators on the intensity of the gene expression related to Toll-like receptor (TLR) signal pathway.