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NCT06012110 · ClinicalTrials.gov registry record · NA
Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
A NA study, sponsored by Nova Southeastern University.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT06012110 is a NA study that has completed, run by Nova Southeastern University. The registered enrollment target is 6 participants.
The verdict
NCT06012110, a NA study, has completed, sponsored by Nova Southeastern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to determine if non-invasive electrical stimulation, using an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can reduce muscle spasms (spasticity) and improve walking function in patients with primary lateral sclerosis. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention, treatment and post-intervention assessments. The assessments will consist of a complete physical exam by the clinic neurologist followed by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance. Patient's will rate their perceived spasticity pre, immediately post and 24 hours post treatment. The treatment involves one 30-minute electrical stimulation session, which includes application of electrode pads to the patients back and abdomen. The patient will lay supine (on their back) with a pillow placed under their knees for comfort. The pads will then be connected to an FDA approved electrical stimulator. The electrical stimulator will be turned on and current adjusted to the individual patient based on small muscle contractions in their legs. Once the current is set, the patient will lay supine for 30 minutes. After 30 minutes, the device will be turned off and electrode pads removed.
Interventions
- DEVICE Transcutaneous electrical stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2024-08-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06012110
The ClinicalTrials.gov registry entry for NCT06012110 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nova Southeastern University, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous electrical stimulation is the first listed.
NCT06012110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06012110 about?
NCT06012110 is a clinical study titled "Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis". The goal of this clinical trial is to determine if non-invasive electrical stimulation, using an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can reduce muscle spasms (spasticity) and improve walking function in patients with primary lateral sclerosis. Parti...
What is the current status of trial NCT06012110?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2023-08-28. Estimated completion is 2024-08-22.
What interventions are being tested in trial NCT06012110?
The interventions under investigation include: Transcutaneous electrical stimulation (DEVICE).
Who is sponsoring clinical trial NCT06012110?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
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