Essential TremorNCT03560622
Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
A study testing multi-modality neuroimaging in people with Essential Tremor, run by Vibhor Krishna at 1 site in United States.
Trial summary
Focused ultrasound for Essential Tremor is an FDA approved treatment performed by neurosurgeons at the Ohio State Center for Neuromodulation that utilizes ultrasound technology to create a lesion in the thalamus of Essential Tremor patients. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- multi-modality neuroimaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The tremor diagnosis, disability and medically refractory status are agreed upon by at least two movement disorder trained physicians (neurologists and/or neurosurgeons).
- The patient is deemed suitable for surgical therapy for tremor with VIM targeting.
- The patient is willing to participate in the study and provides written informed consent.
- The patient is able to clearly communicate clinical findings with the clinical team.
- The patient is willing to participate in at least one follow-up visit at 3 or 6 months.
- In order to maintain uniformity of image acquisition only patients undergoing imaging with the 3T MRI at The Ohio State University Wexner Medical Center will be included.
Who cannot join
- Medically unstable - uncontrolled hypertension, coronary artery disease, significant pulmonary problems, active history of bleeding disorders or anticoagulation.
- Other diagnoses of tremor like Parkinson's disease, traumatic tremor, dystonic tremor, and/or tremor associated with multiple sclerosis
- Unwilling or unable to undergo awake tremor surgery.
- Tremor patients undergoing surgery with targets other than the VIM.
- Significant motion artifact in imaging.
- Unable to undergo 3T MRI imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery
Focused ultrasound for Essential Tremor is an FDA approved treatment performed by neurosurgeons at the Ohio State Center for Neuromodulation that utilizes ultrasound technology to create a lesion in the thalamus of Essential Tremor patients. In order to improve long term effectiveness and reduce potential for side effects, brain imaging may be used to examine the functional connectivity of certain brain networks during the procedure. In order to investigate functional connectivity changes with these long term goals in mind, in this study neuroimaging will be taken immediately before, immediately after, and 24 hours after the focused ultrasound procedure for 10 Essential Tremor patients. One series of neuroimaging will also be conducted for 20 healthy control subjects to serve as a comparison. This study will not introduce any risks above standard of care, and may lead to improved long term outcomes of patients undergoing the Focused Ultrasound procedure.
Read the detailed description
To calculate the connectivity correlates of tremor (CCT) by analyzing and comparing functional connectivity in the tremor network in ET patients and healthy controls. The fMRI data will be acquired in two separate conditions: t-fMRI and rs-fMRI. a. For t-fMRI, patients will perform simple repetitive tasks (e.g. finger tapping, hand grasping) to identify activation clusters within tremor network. Functional connectivity between the clusters will be calculated by creating cross-correlation matrices. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. b. For rs-fMRI the hubs within tremor network will be identified with a state-of-the-art multimodality atlas. Cross-correlation matrices will be created to calculate measures of functional connectivity. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. 2. To study changes in functional connectivity in the tremor network before, immediate postoperative and and 24-hours after FUS-T in ET patients. a. The CCT will be calculated and compared between baseline, immediate postoperative and 24-hours post-operative conditions to determine the effect of FUS-T. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and for rs-fMRI. b. The CCT in immediate postoperative and 24-hours post-operative condition among ET patients will be compared to healthy controls to determine whether FUS-T restored the abnormal connectivity in tremor network. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and rs-fMRI.
- Conditions
- Essential Tremor
- Being tested
- multi-modality neuroimaging
- Keywords
- focused ultrasound, fMRI
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-modality neuroimagingDevice
multi-modality neuroimaging consists of structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI).
| Study group | Role | What they receive |
|---|---|---|
| ET cohort | Active comparator | Ten adults with refractory ET (ET cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). In addition the ET cohort will also undergo imaging with the identical protocol immediately after and 24 hours after FUS-T. Receives: Device: multi-modality neuroimaging |
| control cohort | Experimental | Twenty adult healthy controls (control cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). Receives: Device: multi-modality neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
connectivity correlates of tremor (CCT)
CCT will be calculated by analyzing and comparing functional connectivity in the tremor network in ET patients and healthy controls. The fMRI data will be acquired in two separate conditions: t-fMRI and rs-fMRI. Both t-fMRI and rs-MRI will be calculated based upon functional connectivity between the dentate nucleus, ventral intermediate nucleus, globus pallidus, motor and premotor cortex sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls.
Measured: during the surgical procedure
Secondary outcomes (1)
changes in functional connectivity
- To study changes in functional connectivity in the tremor network before, immediate postoperative and and 24-hours after FUS-T in ET patients.
- The CCT will be calculated and compared between baseline, immediate postoperative and 24-hours post-operative conditions to determine the effect of FUS-T. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and for rs-fMRI.
- The CCT in immediate postoperative and 24-hours post-operative condition among ET patients will be compared to healthy controls to determine whether FUS-T restored the abnormal connectivity in tremor network. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and rs-fMRI.
Measured: immediately post-operative and 24-hours after surgery for ET patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Ten adults with refractory ET (ET cohort) and 20 healthy controls (control cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). In addition the ET cohort will also undergo imaging with the identical protocol immediately after and 24 hours after FUS-T.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vibhor Krishna
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Focused Ultrasound Foundation
- Responsible party
- Sponsor-investigator, Vibhor Krishna, Ohio State University
- Investigators
- Vibhor Krishna, MD SM, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560622
- Sponsor's protocol ID
- 2018H0035
- Status last verified
- Feb 2021
- First submitted
- 6 Jun 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery
- ClinicalTrials.gov ID
- NCT03560622
- Acronym / sponsor ID
- 2018H0035
- Conditions
- Essential Tremor
- Keywords
- focused ultrasound, fMRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vibhor KrishnaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Focused Ultrasound Foundation
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jun 2018 (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.
Focused ultrasound for Essential Tremor is an FDA approved treatment performed by neurosurgeons at the Ohio State Center for Neuromodulation that utilizes ultrasound technology to create a lesion in the thalamus of Essential Tremor patients. In order to improve long term effectiveness and reduce potential for side effects, brain imaging may be used to examine the functional connectivity of certain brain networks during the procedure. In order to investigate functional connectivity changes with these long term goals in mind, in this study neuroimaging will be taken immediately before, immediately after, and 24 hours after the focused ultrasound procedure for 10 Essential Tremor patients. One series of neuroimaging will also be conducted for 20 healthy control subjects to serve as a comparison. This study will not introduce any risks above standard of care, and may lead to improved long term outcomes of patients undergoing the Focused Ultrasound procedure.
Detailed description
To calculate the connectivity correlates of tremor (CCT) by analyzing and comparing functional connectivity in the tremor network in ET patients and healthy controls. The fMRI data will be acquired in two separate conditions: t-fMRI and rs-fMRI. a. For t-fMRI, patients will perform simple repetitive tasks (e.g. finger tapping, hand grasping) to identify activation clusters within tremor network. Functional connectivity between the clusters will be calculated by creating cross-correlation matrices. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. b. For rs-fMRI the hubs within tremor network will be identified with a state-of-the-art multimodality atlas. Cross-correlation matrices will be created to calculate measures of functional connectivity. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. 2. To study changes in functional connectivity in the tremor network before, immediate postoperative and and 24-hours after FUS-T in ET patients. a. The CCT will be calculated and compared between baseline, immediate postoperative and 24-hours post-operative conditions to determine the effect of FUS-T. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and for rs-fMRI. b. The CCT in immediate postoperative and 24-hours post-operative condition among ET patients will be compared to healthy controls to determine whether FUS-T restored the abnormal connectivity in tremor network. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and rs-fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ten adults with refractory ET (ET cohort) and 20 healthy controls (control cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). In addition the ET cohort will also undergo imaging with the identical protocol immediately after and 24 hours after FUS-T.
| Arm | Type | Receives |
|---|---|---|
| ET cohort | Active comparator | Device: multi-modality neuroimagingTen adults with refractory ET (ET cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). In addition the ET cohort will also undergo imaging with the identical protocol immediately after and 24 hours after FUS-T. |
| control cohort | Experimental | Device: multi-modality neuroimagingTwenty adult healthy controls (control cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The tremor diagnosis, disability and medically refractory status are agreed upon by at least two movement disorder trained physicians (neurologists and/or neurosurgeons).
- The patient is deemed suitable for surgical therapy for tremor with VIM targeting.
- The patient is willing to participate in the study and provides written informed consent.
- The patient is able to clearly communicate clinical findings with the clinical team.
- The patient is willing to participate in at least one follow-up visit at 3 or 6 months.
Key exclusion criteria (6 listed)
- Medically unstable - uncontrolled hypertension, coronary artery disease, significant pulmonary problems, active history of bleeding disorders or anticoagulation.
- Other diagnoses of tremor like Parkinson's disease, traumatic tremor, dystonic tremor, and/or tremor associated with multiple sclerosis
- Unwilling or unable to undergo awake tremor surgery.
- Tremor patients undergoing surgery with targets other than the VIM.
- Significant motion artifact in imaging.
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 |
|---|---|---|
| multi-modality neuroimagingmulti-modality neuroimaging consists of structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI). | Device | ET cohort, control cohort |
Primary outcome
connectivity correlates of tremor (CCT)
Time frame: during the surgical procedure
CCT will be calculated by analyzing and comparing functional connectivity in the tremor network in ET patients and healthy controls. The fMRI data will be acquired in two separate conditions: t-fMRI and rs-fMRI. Both t-fMRI and rs-MRI will be calculated based upon functional connectivity between the dentate nucleus, ventral intermediate nucleus, globus pallidus, motor and premotor cortex sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls.
1 secondary outcome
changes in functional connectivity
Time frame: immediately post-operative and 24-hours after surgery for ET patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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.
Vibhor Krishna, MD SM principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-modality neuroimaging in people with Essential Tremor, run by Vibhor Krishna 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
connectivity correlates of tremor (CCT) (time frame: during the surgical procedure). 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 24 Feb 2021.