Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy

NCT03560622 | Active Not Recruiting FDA Device

• 1 other identifier: 2018H0035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Essential Tremor

Keywords

focused ultrasound; fMRI

Outcome Measures

Primary Outcomes (1)

• 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.

  during the surgical procedure

Secondary Outcomes (1)

• changes in functional connectivity

  immediately post-operative and 24-hours after surgery for ET patients

Study Arms (2)

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.

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)).

Device: multi-modality neuroimaging

Interventions

multi-modality neuroimaging DEVICE

multi-modality neuroimaging consists of structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI).

ET cohort; control cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vibhor Krishna: lead
• National Institutes of Health (NIH): collaborator
• Focused Ultrasound Foundation: collaborator

Study Sites (1)

The Ohio State Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vibhor Krishna, MD SM

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor- Neurological Surgery

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

US (1)