Trial Outcomes & Findings for Non-invasive Cervical Electrical Stimulation for SCI (NCT NCT03414424)
NCT ID: NCT03414424
Last Updated: 2023-11-29
Results Overview
Effect of cervical electrical stimulation (CES) on concurrent finger or wrist active movements will be measured via root-mean-square of ongoing muscle activity in various hand and forearm muscles.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
up to one day
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Able Bodied
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
Spinal Cord Injured
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Able Bodied
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
Spinal Cord Injured
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
|---|---|---|
|
Overall Study
Screened out after consent
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Non-invasive Cervical Electrical Stimulation for SCI
Baseline characteristics by cohort
| Measure |
Able Bodied
n=15 Participants
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
Spinal Cord Injured
n=15 Participants
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
CES at rest: CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
CES plus active hand or wrist movements: CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
2 Participants
n=7 Participants
|
2 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
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to one dayPopulation: Data collection for this outcome was plagued with technical problems. The relative timing of cervical stimulation relative to active effort was irregularly applied. Grant funding expired. It is not possible to analyze the data collected for this aim.
Effect of cervical electrical stimulation (CES) on concurrent finger or wrist active movements will be measured via root-mean-square of ongoing muscle activity in various hand and forearm muscles.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to one dayPopulation: Two enrolled spinal cord injury (SCI) participants failed screening. Data for transcranial magnetic stimulation (TMS) were excluded from two more SCI participants who were found after screening to either have unacceptable electrical background electromyographic activity or unreliable responses in resting muscle during TMS.
Response of the target hand muscle to transcranial magnetic stimulation (delivered at 120% of resting motor threshold) with or without a conditioning cervical electrical stimulator pulse (delivered at 90% of resting motor threshold) timed to arrive at cervical synapses 2 milliseconds after transcranial pulse arrival. Response is expressed as percentage change relative to the response to unconditioned transcranial magnetic stimulation.
Outcome measures
| Measure |
Able-bodied
n=15 Participants
Volunteers without spinal cord injury.
|
Spinal Cord Injury
n=11 Participants
Participants with chronic SCI between levels C2-C8
|
|---|---|---|
|
Electromyographic Responses to Transcranial Magnetic and Cervical Electrical Stimulation at Rest
|
6.1 % change from unconditioned TMS.
Standard Error 8.9
|
32.0 % change from unconditioned TMS.
Standard Error 27.8
|
Adverse Events
Able-bodied
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Spinal Cord Injury
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Able-bodied
n=15 participants at risk
Volunteers without spinal cord injury.
|
Spinal Cord Injury
n=15 participants at risk
Participants with chronic SCI between levels C2-C8
|
|---|---|---|
|
Nervous system disorders
Scalp pain/Headache
|
20.0%
3/15 • 1 week
|
20.0%
3/15 • 1 week
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.3%
2/15 • 1 week
|
20.0%
3/15 • 1 week
|
|
General disorders
Sleepy
|
0.00%
0/15 • 1 week
|
6.7%
1/15 • 1 week
|
|
Psychiatric disorders
Depressed mood
|
6.7%
1/15 • 1 week
|
0.00%
0/15 • 1 week
|
|
Nervous system disorders
Paresthesias
|
6.7%
1/15 • 1 week
|
0.00%
0/15 • 1 week
|
|
General disorders
Light-headed
|
0.00%
0/15 • 1 week
|
6.7%
1/15 • 1 week
|
|
Nervous system disorders
Metallic taste
|
13.3%
2/15 • 1 week
|
0.00%
0/15 • 1 week
|
|
Psychiatric disorders
Trouble concentrating
|
13.3%
2/15 • 1 week
|
0.00%
0/15 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place