Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy

Running, not enrolling · Not applicable

Conditions studied: Essential Tremor

In brief

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.

Key facts

Study ID

NCT03560622

Run by

Vibhor Krishna

People needed

30

Starts

2018-09-01

Expected to finish

2021-12-31

Last updated by the study team

2021-02-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• The Ohio State Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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