Stroke HemorrhagicNCT03945851
Functional MRI and DTI Analysis of Post VNS Therapy Rehab Changes
A study testing fMRI in people with Stroke Hemorrhagic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Stroke Hemorrhagic
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <80 years.
- Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score of 20 to 50 (inclusive of 20 and 50).
- Ability to communicate, understand, and give appropriate consent. Subjects should be able to follow two-step commands.
- Right- or left-sided weakness of upper extremity.
- Active wrist flexion/extension; active abduction/extension of thumb and at least two additional digits.
Who cannot join
- History of hemorrhagic stroke
- Presence of ongoing dysphagia or aspiration difficulties
- Subject receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry. A list of excluded medications will be provided to investigators.
- Prior injury to vagus nerve, either bilateral or unilateral (e.g. injury during carotid endarterectomy)
- Severe or worse depression (Beck Depression Scale > 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Stroke Hemorrhagic
- Being tested
- fMRI
- Keywords
- vagal nerve stimulator, MRI, functional MRI
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| VNS + Rehabilitation | Experimental | 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. Receives: Procedure: fMRI |
| Control VNS | Active comparator | 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. Receives: Procedure: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Matter Density
White matter track density will be quantified using fMRI and DTI scans.
Measured: An average of 7 days after Implantation (Pre-Rehabilitation)
White Matter Density
White matter track density will be quantified using fMRI and DTI scans.
Measured: After 6 weeks of treatment (Post-Rehabilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start4 Apr 2019
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke HemorrhagicStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhavya Shah, University of Texas Southwestern Medical Center
- Investigators
- Bhavya Shah, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945851
- Sponsor's protocol ID
- STU-2018-0175
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI and DTI Analysis of Post VNS Therapy Rehab Changes
- ClinicalTrials.gov ID
- NCT03945851
- Acronym / sponsor ID
- STU-2018-0175
- Conditions
- Stroke Hemorrhagic
- Keywords
- vagal nerve stimulator, MRI, functional MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
| Arm | Type | Receives |
|---|---|---|
| VNS + Rehabilitation | Experimental | Procedure: fMRIThis 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. |
| Control VNS | Active comparator | Procedure: fMRIThis 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 <80 years.
- Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score of 20 to 50 (inclusive of 20 and 50).
- Ability to communicate, understand, and give appropriate consent. Subjects should be able to follow two-step commands.
Key exclusion criteria (14 listed)
- History of hemorrhagic stroke
- Presence of ongoing dysphagia or aspiration difficulties
- Subject receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry. A list of excluded medications will be provided to investigators.
- Prior injury to vagus nerve, either bilateral or unilateral (e.g. injury during carotid endarterectomy)
- Severe or worse depression (Beck Depression Scale > 29) (Beck et al., 1961)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIAll 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. | Procedure or surgery | Control VNS, VNS + Rehabilitation |
Primary outcome
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.
White Matter Density
Time frame: After 6 weeks of treatment (Post-Rehabilitation)
White matter track density will be quantified using fMRI and DTI scans.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavya Shah, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Stroke Hemorrhagic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Matter Density (time frame: An average of 7 days after Implantation (Pre-Rehabilitation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.