NCT01731847 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bülow M, Speyer R, Baijens L, Woisard V, Ekberg O
Neuromuscular electrical stimulation (NMES) in stroke patients with oral and pharyngeal dysfunction. Dysphagia. 2008 Sep;23(3):302-9. doi: 10.1007/s00455-007-9145-9. Epub 2008 Apr 25.
Crary MA, Mann GD, Groher ME
Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20.
Freed ML, Freed L, Chatburn RL, Christian M
Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
Langmore SE, Miller RM
Behavioral treatment for adults with oropharyngeal dysphagia. Arch Phys Med Rehabil. 1994 Oct;75(10):1154-60. Review.
Leder SB
Serial fiberoptic endoscopic swallowing evaluations in the management of patients with dysphagia. Arch Phys Med Rehabil. 1998 Oct;79(10):1264-9.
Mann G, Hankey GJ, Cameron D
Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis. 2000 Sep-Oct;10(5):380-6.
Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E
Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol. 2007 Jan;116(1):36-44.

Combined Neuromuscular Electrical Stimulation (NMES) With Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia

Details for clinical trial NCT01731847

Clinical trial NCT01731847 - References