Reviewed by Michael Gill, B. Sc.
Image of Foothill Medical Centre in Calgary, Canada.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Focused Ultrasoundfor Obsessive-Compulsive Disorder

18+
All Sexes
The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e 'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the lesion in the anterior limb of the internal capsule. Patients will be clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At every follow-up visit, patients will be evaluated for general health, neurological changes, as well as for device/procedure related adverse events. Imaging will also be performed with positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure. Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of the procedure for patients, and the technical ability of heating the ALIC to lesional temperatures.
Waitlist Available
Has No Placebo
Foothill Medical Centre (+1 Sites)Nir Lipsman, MD, PhD
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Most Recent Focused Ultrasound Clinical Trials

What Are Focused Ultrasound Clinical Trials?

Also referred to as high-intensity focused ultrasound (HIFU), focused ultrasound (FUS) is a particular procedure that utilizes sound waves to treat various medical conditions. The radiofrequency will heat up and then change or destroy tiny pieces of body tissue without negatively impacting surrounding tissue. These non-invasive ultrasounds are performed while the patient is awake. They are extremely accurate and precise and offer a quick recovery.

Why Are Focused Ultrasounds Being Studied in Clinical Trials?

Currently, the FDA has approved focused ultrasound for the treatment of both Parkinson’s disease and essential tremors. Clinical trials are underway for other conditions to determine the efficiency of treatment with focused ultrasound.

Studying the use of FUS and its potential ability to treat various conditions can help patients avoid surgery and find relief from symptoms related to incurable conditions.

How Do Focused Ultrasounds Work?

Similar to the way a magnifying glass is able to focus sunlight on a single point, FUS utilizes an acoustic lens in order to focus multiple sound waves on a particular part of the body. These waves are guided by MRI so that only the diseased tissue in the body is targeted. An MRI thermal imaging system is used to measure the changes in skull temperature for the safety of patients.

Conditions and Symptoms Focused Ultrasound Can Help With

FUS helps with the treatment of Parkinson’s disease and essential tremor. Research has shown promising results for the following conditions:

  • Movement Disorders
  • Uterine Fibroids
  • Metastatic Breast Cancer

As more research is performed, more symptoms and conditions will likely be added to the list.

What Are Some of the Breakthrough Clinical Trials Involving Focused Ultrasound?

There are numerous clinical trials, like those on Parkinson’s, that have shown the safety and efficacy of FUS on different conditions.

Parkinson’s Disease

A review of 11 different preclinical studies has shown promise for the use of FUS on patients with Parkinson’s disease. These studies showed the safety of FUS and its benefits related to motor behavior. It appears that this procedure can play a therapeutic role in changing the Parkinson’s disease process. While additional research is necessary, FUS appears to be a powerful and effective procedure for Parkinson’s disease.

Metastatic Breast Cancer

This study explored the potential of using FUS on patients who had localized breast cancer. Results showed that there were no adverse side effects when undergoing the procedure, and the treated tumor cells lost the abilities of proliferation, metastasis, and invasion.

Who Are the Key Opinion Leaders on Focused Ultrasound Clinical Trial Research?

Howard Eisenberg, MD

Howard Eisenberg has been an integral part of the FUS program at the University of Maryland for more than a decade. He is currently the Raymond K. Thompson, MD, Chair in Neurosurgery and uses focused ultrasounds primarily for the treatment of Parkinson’s disease, essential tremors, and pain.

Nir Lipsman, MD, PhD

Nir Lipsman is the Director of the Harquail Centre for Neuromodulation as well as the Focused Ultrasound Centre of Excellence at the Sunnybrook Health Sciences Centre. He is conducting a clinical trial that investigates the use of focused ultrasound to deliver antibodies to patients who have been diagnosed with metastatic breast cancer.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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