Trial Outcomes & Findings for Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI (NCT NCT04854057)
NCT ID: NCT04854057
Last Updated: 2024-01-10
Results Overview
Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)
Results posted on
2024-01-10
Participant Flow
Participant milestones
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI
Baseline characteristics by cohort
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=1 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=2 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Upper Extremity Function
Round 1
|
39 units on a scale
n=5 Participants
|
91 units on a scale
n=7 Participants
|
74.7 units on a scale
n=5 Participants
|
|
Upper Extremity Function
Round 2
|
47 units on a scale
n=5 Participants
|
90.5 units on a scale
n=7 Participants
|
76 units on a scale
n=5 Participants
|
|
Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 1 Baseline
|
3.5 kg
n=5 Participants
|
14.3 kg
n=7 Participants
|
10.7 kg
n=5 Participants
|
|
Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 2 Baseline
|
3.6 kg
n=5 Participants
|
17.45 kg
n=7 Participants
|
12.8 kg
n=5 Participants
|
|
Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 1 Baseline
|
0 kg
n=5 Participants
|
12.7 kg
n=7 Participants
|
8.5 kg
n=5 Participants
|
|
Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 2 Baseline
|
0 kg
n=5 Participants
|
15.1 kg
n=7 Participants
|
10.0 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)Population: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.
Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.
Outcome measures
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=1 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=2 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|
|
Change in Upper Extremity Function
Round 1 Day 15
|
6 score on a scale
Interval 6.0 to 6.0
|
7 score on a scale
Interval -3.0 to 17.0
|
|
Change in Upper Extremity Function
Round 1 Week 8
|
8 score on a scale
Interval 8.0 to 8.0
|
-0.5 score on a scale
Interval -5.0 to 4.0
|
|
Change in Upper Extremity Function
Round 2 Day 5
|
-1 score on a scale
Interval -1.0 to -1.0
|
11.5 score on a scale
Interval 6.0 to 17.0
|
|
Change in Upper Extremity Function
Round 1 Day 5
|
-2 score on a scale
Interval -2.0 to -2.0
|
6 score on a scale
Interval -1.0 to 13.0
|
|
Change in Upper Extremity Function
Round 1Day 10
|
5 score on a scale
Interval 5.0 to 5.0
|
7 score on a scale
Interval -1.0 to 15.0
|
|
Change in Upper Extremity Function
Round 2 Day 10
|
1 score on a scale
Interval 1.0 to 1.0
|
18 score on a scale
Interval 18.0 to 18.0
|
|
Change in Upper Extremity Function
Round 2 Day 15
|
-2 score on a scale
Interval -2.0 to -2.0
|
17 score on a scale
Interval 17.0 to 17.0
|
|
Change in Upper Extremity Function
Round 2 Week 8
|
0 score on a scale
Interval 0.0 to 0.0
|
16 score on a scale
Interval 16.0 to 16.0
|
PRIMARY outcome
Timeframe: Once each intervention week (days 5, 10, and 15), and once at followup (week 8)Population: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.
Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.
Outcome measures
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=1 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=2 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 1 Day 5
|
-.47 kg
Interval -0.47 to -0.47
|
1.65 kg
Interval 0.0 to 3.3
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 1 Day 10
|
-.63 kg
Interval -0.63 to -0.63
|
1.63 kg
Interval -0.33 to 3.6
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 1 Day 15
|
-.33 kg
Interval -0.33 to -0.33
|
2.63 kg
Interval -0.17 to 5.43
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 1 Week 8
|
.10 kg
Interval 0.1 to 0.1
|
3.13 kg
Interval 0.4 to 5.87
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 2 Day 5
|
-.13 kg
Interval -0.13 to -0.13
|
0.68 kg
Interval 0.0 to 1.37
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 2 Day 10
|
.63 kg
Interval 0.63 to 0.63
|
1.53 kg
Interval 1.53 to 1.53
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 2 Day 15
|
.47 kg
Interval 0.47 to 0.47
|
-0.43 kg
Interval -0.43 to -0.43
|
|
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Round 2 Week 8
|
.50 kg
Interval 0.5 to 0.5
|
-0.10 kg
Interval -0.1 to -0.1
|
PRIMARY outcome
Timeframe: Once each intervention week (days 5, 10, and 15), and once at followup (week 8)Population: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.
Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.
Outcome measures
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=1 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First
n=2 Participants
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 1 Day 5
|
0 kg
Interval 0.0 to 0.0
|
0.98 kg
Interval 0.0 to 1.97
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 2 Day 15
|
.17 kg
Interval 0.17 to 0.17
|
2.40 kg
Interval 2.4 to 2.4
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 2 Week 8
|
0 kg
Interval 0.0 to 0.0
|
1.37 kg
Interval 1.37 to 1.37
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 1 Day 10
|
0 kg
Interval 0.0 to 0.0
|
0.30 kg
Interval 0.0 to 0.6
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 1 Day 15
|
.17 kg
Interval 0.17 to 0.17
|
0.77 kg
Interval 0.0 to 1.53
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 1 Week 8
|
0 kg
Interval 0.0 to 0.0
|
2.35 kg
Interval 0.0 to 4.7
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 2 Day 5
|
0 kg
Interval 0.0 to 0.0
|
-2.28 kg
Interval -4.57 to 0.0
|
|
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Round 2 Day 10
|
0 kg
Interval 0.0 to 0.0
|
0.27 kg
Interval 0.27 to 0.27
|
Adverse Events
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1
n=1 participants at risk
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2
n=1 participants at risk
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1
n=2 participants at risk
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2
n=2 participants at risk
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Washout (1 month)
Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.
Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).
Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pressure ulcer
|
0.00%
0/1 • 199 days
|
0.00%
0/1 • 199 days
|
0.00%
0/2 • 199 days
|
50.0%
1/2 • Number of events 1 • 199 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place