Trial Outcomes & Findings for High Frequency Impulse Therapy for Neuropathic Pain in NMOSD (NCT NCT04614454)
NCT ID: NCT04614454
Last Updated: 2025-04-30
Results Overview
The NRS scale is an 11 point scale (0-10) with 0 as no pain and 10 as worst pain to determine the pain level. The result posted here is difference between the NRS at baseline and the NRS at 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
4 weeks from baseline to completion of the experimental phase.
Results posted on
2025-04-30
Participant Flow
Participants were recruited via social media outreach and directly in the clinic at the Neuroimmunology Clinic and Research Laboratory at Massachusetts General Hospital. The trial was entirely virtual, and the research coordinator screened potential participants by phone.
Inclusion criteria included age 18+ years, diagnosis of NMOSD, presence of aquaporin-4 immunoglobulin (AQP4 IgG) serum antibodies, pain lasting ≥ 3 months attributable to a previous inflammatory spinal cord lesion, and pain rated at a level of ≥ 4 on an 11-point Numeric Rating Scale (NRS).12 Exclusion criteria included spinal cord relapses or surgery to treat a pain-related condition within 6 months of enrollment, presence of neuropathic pain due to non-NMOSD-related identified causes.
Participant milestones
| Measure |
Experimental Arm
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
Sham Arm
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=23 Participants
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
Sham Arm
n=23 Participants
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
51.1 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
52.4 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 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
|
PRIMARY outcome
Timeframe: 4 weeks from baseline to completion of the experimental phase.Population: All individuals who completed their baseline and week 4 assessment were included in the analysis as randomized, regardless of actual device usage or further participation in the trial. Twenty-one participants in the sham arm and 19 in the TENS arm met these criteria.
The NRS scale is an 11 point scale (0-10) with 0 as no pain and 10 as worst pain to determine the pain level. The result posted here is difference between the NRS at baseline and the NRS at 4 weeks.
Outcome measures
| Measure |
Experimental Arm
n=19 Participants
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy: The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
|
Sham Arm
n=21 Participants
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy - Sham: This device looks like the experimental device but does not provide the electrical current.
|
|---|---|---|
|
Change in Pain Score on the Numerical Rating Score (NRS)
|
2.2 units on a scale
Standard Deviation 2.2
|
1.3 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 4 weeks from baseline to completion of the experimental phase.The NRS scale is an 11 point scale (0-10) with 0 as no pain and 10 as worst pain to determine the pain level. The result posted here is difference between the worst NRS at baseline and the worst NRS at 4 weeks.
Outcome measures
| Measure |
Experimental Arm
n=19 Participants
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy: The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
|
Sham Arm
n=21 Participants
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy - Sham: This device looks like the experimental device but does not provide the electrical current.
|
|---|---|---|
|
"Worst" Pain Score on the NRS Scale
|
1.0 units on a scale
Standard Deviation 2.1
|
1.4 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 4 weeks from baseline to completion of the experimental phase.The number of patients who withdraw because of poor compliance.
Outcome measures
| Measure |
Experimental Arm
n=23 Participants
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy: The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
|
Sham Arm
n=23 Participants
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy - Sham: This device looks like the experimental device but does not provide the electrical current.
|
|---|---|---|
|
Withdrawal From Trial
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 weeks from baseline to completion of the experimental phase.SF36 quality of life questionnaire summary score. The SF-36 scale range is from 0 to 100, with higher scores indicating better health and lower scores indicating poorer health across all eight domains measured by the survey; essentially, a score of 0 represents the worst possible health and 100 represents the best possible health.
Outcome measures
| Measure |
Experimental Arm
n=19 Participants
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy: The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
|
Sham Arm
n=21 Participants
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
High Frequency Impulse Therapy - Sham: This device looks like the experimental device but does not provide the electrical current.
|
|---|---|---|
|
Quality of Life Survey
|
14.7 score on a scale
Standard Deviation 13.5
|
10.2 score on a scale
Standard Deviation 14.5
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Sham Arm
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Arm
n=23 participants at risk
Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
Sham Arm
n=23 participants at risk
The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.
|
|---|---|---|
|
Nervous system disorders
Increased pain
|
13.0%
3/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
17.4%
4/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Worsened vision
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Itchiness
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Burning discomfort
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Muscle twitching
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
8.7%
2/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Numbness
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Muscle spasms
|
8.7%
2/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Nervous system disorders
Phantom feelings
|
13.0%
3/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
13.0%
3/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
8.7%
2/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
0.00%
0/23 • 2 years
Addressing this issue: "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided." No adverse event data from the planned open label arm was collected. There is no data to report.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place