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NCT01381354 · ClinicalTrials.gov registry record · Phase 1
Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
A Phase 1 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01381354: Completed Phase 1 study, sponsored by University of Iowa.
NCT01381354 is a Phase 1 study that has completed, run by University of Iowa. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381354, a Phase 1 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The study will use a multimodal therapeutic lifestyle intervention consisting of a study diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food allergy, meditation, self massage, progressive exercise and neuromuscular electrical stimulation for rehabilitation of gait and fatigue disability in the setting of secondary and primary progressive multiple sclerosis with gait disability.
Primary Outcome
Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)
Interventions
- OTHER Progressive exercise
- DIETARY_SUPPLEMENT Omega 3 fatty acids
- DEVICE Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV
- OTHER Modified paleolithic diet
- DIETARY_SUPPLEMENT Full Spectrum vitamin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01381354 record still lists
NCT01381354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Progressive exercise is the first listed.
NCT01381354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381354 about?
NCT01381354 is a clinical study titled "Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)". The study will use a multimodal therapeutic lifestyle intervention consisting of a study diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food allergy, meditation, self massage, progressive exercise and neuromuscular electrical stimulation for rehabilitation of ga...
What is the current status of trial NCT01381354?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-10. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01381354?
The interventions under investigation include: Progressive exercise (OTHER), Omega 3 fatty acids (DIETARY_SUPPLEMENT), Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV (DEVICE), Modified paleolithic diet (OTHER), Full Spectrum vitamin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01381354?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381354's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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