Trial Outcomes & Findings for Scrambler Trial for Pain in NMOSD (NCT NCT03452176)
NCT ID: NCT03452176
Last Updated: 2020-05-05
Results Overview
Will be determined by how many participants say "yes" to the following question, "Would you want to continue the treatment if it were available?"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
10 days
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
Scrambler
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Scrambler Trial for Pain in NMOSD
Baseline characteristics by cohort
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean
|
56.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Aquaporin-4 Antibody Seropositive
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysWill be determined by how many participants say "yes" to the following question, "Would you want to continue the treatment if it were available?"
Outcome measures
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Sham Pre
Median NRS scores prior to receiving 10-day sham
|
Sham Post
Median NRS scores directly following 10-day sham
|
|---|---|---|---|---|
|
Acceptability as Assessed by the Number of Participants Responding Yes to a Question
|
7 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 10 daysAdherence to visit schedule will be determined by the number of participants that completed the 10 treatment visits.
Outcome measures
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Sham Pre
Median NRS scores prior to receiving 10-day sham
|
Sham Post
Median NRS scores directly following 10-day sham
|
|---|---|---|---|---|
|
Feasibility as Assessed by Number of Participants That Completed Treatment Visits
|
11 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 10 daysPopulation: Scrambler pre/post compared to sham pre/post using Wilcoxian signed rank
Change in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.
Outcome measures
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Sham Pre
n=11 Participants
Median NRS scores prior to receiving 10-day sham
|
Sham Post
n=11 Participants
Median NRS scores directly following 10-day sham
|
|---|---|---|---|---|
|
Change in Pain Level
|
5.0 score on a scale
Interval 4.25 to 7.0
|
1.5 score on a scale
Interval 0.0 to 2.75
|
5.0 score on a scale
Interval 4.0 to 7.25
|
4.0 score on a scale
Interval 3.5 to 4.75
|
SECONDARY outcome
Timeframe: Baseline, 30 daysChange in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.
Outcome measures
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Sham Pre
Median NRS scores prior to receiving 10-day sham
|
Sham Post
Median NRS scores directly following 10-day sham
|
|---|---|---|---|---|
|
Change in Pain Level
|
4.5 score on a scale
Interval 3.375 to 5.125
|
5.0 score on a scale
Interval 4.25 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 60 daysChange in NRS pain score (score ranges from 1 to 10 with 1 being "No pain" and 10 being "Worst pain") will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value.
Outcome measures
| Measure |
Scrambler
n=11 Participants
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 Participants
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
Sham Pre
Median NRS scores prior to receiving 10-day sham
|
Sham Post
Median NRS scores directly following 10-day sham
|
|---|---|---|---|---|
|
Change in Pain Level
|
4.5 score on a scale
Interval 2.5 to 5.75
|
5.0 score on a scale
Interval 4.5 to 6.5
|
—
|
—
|
Adverse Events
Scrambler
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham-Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Scrambler
n=11 participants at risk
This arm will receive the Scrambler intervention for 1 hour daily x10 days.
Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
|
Sham-Control
n=11 participants at risk
This arm will receive the Sham-Control intervention for 1 hour daily x10 days.
Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
|
|---|---|---|
|
Nervous system disorders
Charles Bonnet Syndrome
|
9.1%
1/11 • Number of events 1 • 60 days
|
0.00%
0/11 • 60 days
|
|
Nervous system disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • 60 days
|
0.00%
0/11 • 60 days
|
|
Skin and subcutaneous tissue disorders
Skin sensitivity to electrodes
|
9.1%
1/11 • Number of events 1 • 60 days
|
0.00%
0/11 • 60 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/11 • 60 days
|
18.2%
2/11 • Number of events 2 • 60 days
|
|
Infections and infestations
Bacteremia
|
0.00%
0/11 • 60 days
|
9.1%
1/11 • Number of events 2 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place