Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke

NCT03344562 | Terminated Results FDA Device

• 1 other identifier: STU 072016-005
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night. Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes. The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.

Conditions

Cerebrovascular Accident; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Hours of Sleep

  A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep

  7- 24 hour periods

Secondary Outcomes (2)

• Sleep Efficiency

  7-24 hour periods

• Karolinska Sleepiness Scale

  Daily for 7 days

Study Arms (2)

CES Active

EXPERIMENTAL

Active cranial electrical stimulation device

Device: CES

CES Sham

SHAM COMPARATOR

Inactive device identical to the active device.

Device: CES

Interventions

CES DEVICE

Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep.

Also known as: Fisher-Wallace Cranial Electrical Stimulation

CES Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Zale Lipshy University Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Stroke; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Limitations and Caveats

Early termination leading to small numbers of subjects. Data has not been analyzed. There were also technical problems with measurement of primary and secondary outcomes leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Dr. Amy Mathews - ASSISTANT PROFESSOR
• Organization: University of Texas Southwestern Medical Center

Amy.Mathews@UTSouthwestern.edu

214/645-1719

Study Officials

• Kathleen R Bell, MD

  University of Texas

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: February 21, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)