Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 1/26/2019 |
| Start Date: | September 1, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Meghan Dezinno |
| Email: | meghan.dezinno@osumc.edu |
| Phone: | 614-293-2587 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Vibhor Krishna, MD
Phone: 614-695-3141
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