Status:
TERMINATED
Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Cerebrovascular Accident
Sleep Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Ins...
Detailed Description
The purpose of this study is to determine if CES is a reasonable first line alternative to the current standard of care (SOC) which relies on the use of trazodone for patients with subacute stroke. Th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent must be obtained.
- Patients must be admitted to inpatient rehab.
- Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic).
- Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device.
- Subjects must Score a 7 or higher on the ISI.
- Patients must be able to communicate consent and/or desire to discontinue the study.
- Exclusion Criteria 1. Demand or sensing type cardiac pacemaker. 2. Known uncontrolled seizure disorder. 3. Current history of vertigo. 4. Need for continuous O2. 5. Inability to communicate or provide consent. 6. Restricted use or absence of both arms.
- \-
Exclusion
Key Trial Info
Start Date :
February 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03344562
Start Date
February 21 2017
End Date
December 31 2019
Last Update
December 19 2020
Active Locations (1)
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1
Zale Lipshy University Hospital
Dallas, Texas, United States, 75390