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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Functional MRI and DTI Analysis of Post VNS Therapy Rehab Changes

Clinicaltrials.gov identifier NCT03945851

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

The purpose of performing magnetic resonance imaging (MRI) scans on patients undergoing stroke rehabilitation therapy in conjunction with vagal nerve stimulators (VNS) is to determine if the patients clinical improvement correlates to changes that can be identified on MRI of the brain such as degree of blood oxygen level dependent (BOLD) signal, changes in resting state connectivity, and corticospinal tract fiber density. Subjects will be randomized at implant surgery to either the device treatment (rehabilitation and VNS) or control (rehabilitation and Control VNS) groups. All participants of this study are also participants of the STU 062017-071 study and chose to participate in this functional magnetic resonance imaging (fMRI) sub-study. Rehabilitation is standard of care. Both experimental groups and control groups will receive pre-rehabilitation and post-rehabilitation fMRI and diffusion tensor imaging (DTI) scans to quantify their white matter track density. We will analyze this data using the University of Texas Southwestern (UTSW) Advanced Neuroscience Imaging Research (ANSIR) pipeline which can automatically quantify white matter track density on both sides of the brain given the appropriate scans. In this study the VNS device specifically will not be studied. Rather we will be looking at the changes that occur in the brain as a result of using the VNS device during physical rehabilitation. Once the post-rehabilitation scans are completed the patients in the control group will be given the opportunity to crossover into the experimental group and receive physical rehabilitation with the VNS implant turned on. They will have a third MRI session after their round of rehabilitation with the implant turned on in order to quantify their white matter tract density.

  • Condition or Disease:Stroke Hemorrhagic
  • Intervention/Treatment: Procedure: fMRI
  • Phase: N/A
Detailed Description

This study will consist of 2-3 fMRI sessions, depending on group assignment, and span 2 days for each session. It will be done at a single site only, at UTSW. The fMRI tasks will consists of subjects grasping and releasing a handgrip. The VNS implant will be used in this study to determine if having the implant active during physical rehabilitation produces white matter tract changes in the brain visible on fMRI. All subjects in the STU 062017-071 study will receive a VNS implant. And all subjects in this study are also subjects of the STU 062017-071 study. Therefore participants of this study will enroll with the implant already in place. Methods: After passing routine MRI screening, patients who are enrolled in the VNS-REHAB study and consent to participate in the fMRI study will be scanned on a Phillips 3 Tesla Research Magnet (Ingenia, Philips Healthcare, Best, the Netherlands). Patients will be scanned before therapy and the week after therapy. A subset of patients will be scanned 3 times, before therapy, after therapy without activation of the vagal nerve stimulator, and after therapy with activation of the vagal nerve stimulator. Scan Time: Scan time is limited to 15 minutes per session to match manufacture FDA guidelines. Patients will receive two, 15 minute MRI scans over 2 days.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Diagnostic
  • Official Title: Functional MRI and DTI Analysis of Post VNS Therapy Rehab Changes
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Control VNS
This study is only including subjects from the VNS-REHAB study (NCT03131960) who choose to participate in this fMRI sub-study. The active control arm for that study included subject whose stroke treatment is rehabilitation (standard-of-care) with only a minimal amount of VNS at the start of each rehabilitation session.
Procedure: fMRI
All subjects will undergo 2 fMRI sessions. Each of these sessions will span two days, and subjects will spend 15 minutes in the MRI each day. fMRI tasks will consist of subjects grasping and releasing a handgrip. The control arm subjects will be offered a third fMRI session after unblinding and therapy with activation of the VNS.
Experimental: VNS + Rehabilitation
This study is only including subjects from the VNS-REHAB study (NCT03131960) who choose to participate in this fMRI sub-study. The experimental arm for that study includes subjects whose stroke treatment via Vagal Nerve Stimulation (VNS) delivered during rehabilitation.
Procedure: fMRI
All subjects will undergo 2 fMRI sessions. Each of these sessions will span two days, and subjects will spend 15 minutes in the MRI each day. fMRI tasks will consist of subjects grasping and releasing a handgrip. The control arm subjects will be offered a third fMRI session after unblinding and therapy with activation of the VNS.
Outcome Measures
  • Primary Outcome Measures: 1. White Matter Density [ Time Frame: An average of 7 days after Implantation (Pre-Rehabilitation) ]
    White matter track density will be quantified using fMRI and DTI scans.
  • 2. White Matter Density [ Time Frame: After 6 weeks of treatment (Post-Rehabilitation) ]
    White matter track density will be quantified using fMRI and DTI scans.
Eligibility Criteria
  • Ages Eligible for Study: 22 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- This study is only including subjects from the STU 062017-071 (A Pivotal Randomized
Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper
Limb Motor Function After Stroke) study that choose to participate in this fMRI
substudy.

- History of unilateral supratentorial ischemic stroke that occurred at least 9 months
but not more than ten 10 years prior to enrollment.

- Age >22 years and 29) (Beck et al., 1961)

- Unfavorable candidacy for device implant surgery (e.g. history of adverse reactions to
anesthetics, poor surgical candidate in surgeon's opinion, etc)

- Current use of any other stimulation device, such as a pacemaker or other
neurostimulator; current use of any other investigational device or drug

- Medical or mental instability (diagnosis of personality disorder, psychosis, or
substance abuse) that would prevent subject from meeting protocol timeline

- Pregnancy or plans to become pregnant or to breastfeed during the study period

- Current or future requirement of diathermy during the study duration

- Active rehabilitation within 4 weeks prior to consent

- Botox injections or any other non-study active rehabilitation of the upper extremity
within 4 weeks prior to therapy through the post-30 day visit

- Severe spasticity of the upper limb (Modified Ashworth >=3)

- Significant sensory loss. Sensory loss will be measured using the upper Extremity
sensory section of the Fugl Meyer Assessment of Physical Performance. The assessment
addresses light touch (2 items) and proprioception (4 items). The highest points
attained is 12; subjects with scores less than 6 will be excluded from the study.

Contacts and Locations
Contacts

Contact: Bhavya Shah, MD Bhavya.Shah@UTSouthwestern.edu

Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu

Locations

United States, Texas
UT Southwestern Medical Center
Dallas

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Bhavya Shah, MD UT Southwestern Medical Center

More Information
  • Responsible Party: University of Texas Southwestern Medical Center
  • ClinicalTrials.gov Identifier: NCT03945851 History of Changes
  • Other Study ID Numbers: STU-2018-0175
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Texas Southwestern Medical Center: vagal nerve stimulator
    functional MRI
    MRI