Trial Outcomes & Findings for Cervical Electrical Stimulation for ALS (NCT NCT03411863)
NCT ID: NCT03411863
Last Updated: 2022-10-25
Results Overview
These results are derived from peak-to-peak EMG amplitude in the abductor pollicis brevis (APB) muscle in response to transcranial magnetic stimulation (TMS). Values represent the ratio of peak-to-peak APB amplitude when TMS is paired with cervical electrical stimulation (CES) at the indicated timing (in milliseconds) normalized to the response to TMS alone (control).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
up to 1 day
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
Participants Without Neurological Disease
All subjects undergo same full protocol.
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.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
All subjects undergo same full protocol.
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
|
8
|
11
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Participants Without Neurological Disease
All subjects undergo same full protocol.
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.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
All subjects undergo same full protocol.
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
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants Without Neurological Disease
n=8 Participants
All subjects undergo same full protocol.
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.
|
Participants With ALS
n=11 Participants
All subjects undergo same full protocol.
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=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants
|
10 Participants
n=11 Participants
|
17 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=8 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
5 Participants
n=11 Participants
|
8 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
6 Participants
n=11 Participants
|
11 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 Participants
n=8 Participants
|
11 Participants
n=11 Participants
|
19 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Participants who completed at least one session of resting conditioned/non-conditioned stimuli were analyzed.
These results are derived from peak-to-peak EMG amplitude in the abductor pollicis brevis (APB) muscle in response to transcranial magnetic stimulation (TMS). Values represent the ratio of peak-to-peak APB amplitude when TMS is paired with cervical electrical stimulation (CES) at the indicated timing (in milliseconds) normalized to the response to TMS alone (control).
Outcome measures
| Measure |
Participants Without Neurological Disease
n=6 Participants
Participants without neurological disease.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=7 Participants
Participants with ALS.
|
|---|---|---|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES -25 ms
|
6.8 % change compared to TMS alone
Standard Deviation 29.0
|
21.6 % change compared to TMS alone
Standard Deviation 44.7
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES -10 ms
|
8.4 % change compared to TMS alone
Standard Deviation 25.5
|
-6.1 % change compared to TMS alone
Standard Deviation 17.9
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES -2 ms
|
8.0 % change compared to TMS alone
Standard Deviation 24.9
|
3.4 % change compared to TMS alone
Standard Deviation 42.0
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES 0 ms
|
2.7 % change compared to TMS alone
Standard Deviation 53.2
|
38.5 % change compared to TMS alone
Standard Deviation 38.6
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES +2 ms
|
-5.9 % change compared to TMS alone
Standard Deviation 23.6
|
48.3 % change compared to TMS alone
Standard Deviation 67.2
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES +5 ms
|
14.1 % change compared to TMS alone
Standard Deviation 38.7
|
11.2 % change compared to TMS alone
Standard Deviation 39.0
|
|
Electromyographic (EMG) Responses (Rest)
TMS+CES +10 ms
|
14.0 % change compared to TMS alone
Standard Deviation 30.4
|
45.8 % change compared to TMS alone
Standard Deviation 77.0
|
PRIMARY outcome
Timeframe: up to 1 dayPopulation: Unfortunately, this data is uninterpretable due to technically mis-timed synchronization between muscle action and spinal stimulation.
Effect of 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
Adverse Events
Participants Without Neurological Injury
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Participants With ALS
Serious events: 1 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Participants Without Neurological Injury
n=8 participants at risk
All subjects undergo same full protocol.
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.
|
Participants With ALS
n=11 participants at risk
All subjects undergo same full protocol.
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Unrelated hand laceration
|
0.00%
0/8 • 24 hours
|
9.1%
1/11 • Number of events 1 • 24 hours
|
Other adverse events
| Measure |
Participants Without Neurological Injury
n=8 participants at risk
All subjects undergo same full protocol.
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.
|
Participants With ALS
n=11 participants at risk
All subjects undergo same full protocol.
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 24 hours
|
36.4%
4/11 • Number of events 4 • 24 hours
|
|
Skin and subcutaneous tissue disorders
Flushing
|
12.5%
1/8 • Number of events 1 • 24 hours
|
9.1%
1/11 • Number of events 5 • 24 hours
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 24 hours
|
9.1%
1/11 • Number of events 1 • 24 hours
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/8 • 24 hours
|
9.1%
1/11 • Number of events 2 • 24 hours
|
|
Eye disorders
Blurry vision
|
0.00%
0/8 • 24 hours
|
9.1%
1/11 • Number of events 1 • 24 hours
|
|
Nervous system disorders
Light-headed
|
12.5%
1/8 • Number of events 1 • 24 hours
|
0.00%
0/11 • 24 hours
|
|
Gastrointestinal disorders
Metallic taste
|
0.00%
0/8 • 24 hours
|
9.1%
1/11 • Number of events 1 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place