Trial Outcomes & Findings for Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation (NCT NCT03249779)
NCT ID: NCT03249779
Last Updated: 2019-09-04
Results Overview
The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose. The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being "None" and 4 being "Very severe." Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms.
COMPLETED
NA
8 participants
baseline, 2 weeks
2019-09-04
Participant Flow
Participant milestones
| Measure |
Scrambler
All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.
Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Scrambler
n=8 Participants
All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.
Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS
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Age, Continuous
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71 years
n=8 Participants
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Sex: Female, Male
Female
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4 Participants
n=8 Participants
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Sex: Female, Male
Male
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4 Participants
n=8 Participants
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Region of Enrollment
United States
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8 participants
n=8 Participants
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PRIMARY outcome
Timeframe: baseline, 2 weeksThe International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose. The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being "None" and 4 being "Very severe." Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms.
Outcome measures
| Measure |
Scrambler
n=8 Participants
All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.
Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS
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|---|---|
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Change in International Restless Legs Syndrome Rating Scale (IRLS)
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19.5 score on a scale
Standard Deviation 8.03
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PRIMARY outcome
Timeframe: baseline, 1 week post treatment (approximately 3 weeks)The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose. The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being "None" and 4 being "Very severe." Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms.
Outcome measures
| Measure |
Scrambler
n=8 Participants
All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.
Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS
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|---|---|
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Change in International Restless Legs Syndrome Rating Scale (IRLS)
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20.25 score on a scale
Standard Deviation 11.53
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Adverse Events
Scrambler
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place