Trials / Terminated
TerminatedNCT03836989
Electrical Stimulation to Promote Recovery in Bells Palsy
Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.
Detailed description
Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Electrical stimulation device (tens unit) | An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory |
Timeline
- Start date
- 2018-01-22
- Primary completion
- 2019-03-21
- Completion
- 2020-08-31
- First posted
- 2019-02-11
- Last updated
- 2021-05-11
- Results posted
- 2021-05-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03836989. Inclusion in this directory is not an endorsement.