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Electrical Stimulation
High Frequency Impulse Therapy for Neuromyelitis Optica (NMO)
Phase 2
Waitlist Available
Led By Michael Levy, MD, PhD
Research Sponsored by Harvard Medical School (HMS and HSDM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks from baseline to completion of the experimental phase.
Awards & highlights
Study Summary
This trial looks at whether a self-administered electrical nerve stimulator can help relieve neuropathic pain for people with NMOSD.
Who is the study for?
This trial is for adults with Neuromyelitis Optica (NMO) who have stable disease, no recent spinal cord relapses, and are on a consistent medication regimen. Participants must experience neuropathic pain from a spinal lesion, be positive for aquaporin-4 antibody, and not have had certain heart issues or other treatments that could affect the study.Check my eligibility
What is being tested?
The trial tests if using an electrical nerve stimulating device at home can help relieve long-term (>3 months) neuropathic pain in NMO patients. It compares real High Frequency Impulse Therapy to a sham (fake) treatment to see if there's a difference in effectiveness.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the device is applied, muscle twitching during use of the device, discomfort or increased pain if settings are too high, and possible allergic reactions to materials like latex used in electrodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks from baseline to completion of the experimental phase.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from baseline to completion of the experimental phase.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain score on the Numerical Rating Score (NRS)
Secondary outcome measures
"Worst" pain score on the NRS scale
Pain score on the NRS in the extension phase
Quality of life survey
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental armExperimental Treatment1 Intervention
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.
Group II: Sham armPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Harvard Medical School (HMS and HSDM)Lead Sponsor
195 Previous Clinical Trials
1,315,999 Total Patients Enrolled
Harvard Medical SchoolLead Sponsor
29 Previous Clinical Trials
40,803 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,309 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a heart attack or heart disease in the last six months.You have received a nerve block or other treatment for pain in the past month.Your blood test must show that you have the aquaporin-4 antibody.You have had ongoing nerve pain for more than 3 months and rate it as a 4 or higher on the pain scale with faces.You have not had any spinal cord relapses in the last 6 months before joining the study.Your pain should be only in a specific area of your spine.You are currently using or have used an experimental drug for pain relief in the last 30 days.You have had an allergic reaction to transcutaneous electronic nerve stimulation or to latex in the past.You have an implanted device that delivers medication, like the Medtronic Synchromed.You have certain metal implants in your body, like heart stents or pacemakers.You have skin sores that would make it difficult to put on the electrodes.You have other known conditions that could already be causing the same nerve symptoms you're experiencing.You have a current or past history of brain-related conditions like epilepsy, brain damage, or symptomatic brain metastases.You are a man or woman aged 18 years or older diagnosed with NMOSD according to the 2015 NMOSD criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Sham arm
- Group 2: Experimental arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available to participate in this trial?
"Per the data posted on clinicaltrials.gov, this particular study has closed its recruitment phase and is no longer seeking out new participants. Initially published on June 7th 2021 and last updated on April 14th 2022, it appears that other studies have since replaced this one's role in actively recruiting patients—183 to be exact."
Answered by AI
What potential adverse effects should be considered when administering High Frequency Impulse Therapy to a patient?
"High Frequency Impulse Therapy has been assessed to be of a safety grade 2, as this Phase 2 trial lacks efficacy data but does have some evidence for its safe usage."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
New York
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