MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis

NCT02614989 | Unknown

• 1 other identifier: 0556-15-RMB
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS patients with disabling refractory tremor.

Conditions

Multiple Sclerosis

Keywords

Tremor; Thalamotomy

Outcome Measures

Primary Outcomes (1)

• Device or procedure related adverse events reported

  Safety of the MRI guided focused Ultrasound treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 3-Months post-treatment time point. All AEs will be reported.

  3 months

Secondary Outcomes (1)

• Tremor rating scale

  1 month

Study Arms (1)

MRI guided Focused Ultrasound treatment

EXPERIMENTAL

MRI guided focused ultrasound thalamotomy Patients will undergo unilateral thalmotomy using MRI guided Focused Ultrasound intervention for the treatment of the tremor

Procedure: MRI guided focused ultrasound thalamotomy

Interventions

MRI guided focused ultrasound thalamotomy PROCEDURE

MRI guided focused ultrasound thalamotomy

MRI guided Focused Ultrasound treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 18 years and older
• Patients who are able and willing to give informed consent and able to attend all study visits
• Patients with a diagnosis of Multiple sclerosis (MS) as confirmed from clinical history and examination by a neurologist.
• The patient must have disabling tremor from MS as indicated by a score of at least 2 on the Tremor Rating Scale (TRS) baseline global assessments by the examiner and the patient. Or Disabling is defined as significant impairment of the normal functions of daily life as indicated by a score of at least 5 on the Clinical Global Impression (CGI)-Severity scale.or ETRS
• The MS patient must have disabling and medically refractory unilateral or bilateral upper extremity tremor. Patients with associated ipsilateral lower extremity tremor are not excluded.
• The patient must have a history of an unsatisfactory response to medical management. Any patient will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.
• Patients should be on a stable dose of medications for 30 days prior to study entry

You may not qualify if:

• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Significant claustrophobia
• Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
• Subjects with unstable cardiac status
• Severe hypertension
• Current medical condition resulting in abnormal bleeding and/or coagulopathy
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within two weeks of focused ultrasound procedure or drugs known to increase risk or hemorrhage
• History of intracranial hemorrhage
• History of multiple strokes, or a stroke within past 6 months
• Subjects with a history of seizures within the past year
• Subjects with brain tumors
• Are participating or have participated in another clinical trial in the last 30 days
• More than mild non-tremor cerebellar dysfunction (ataxia, dysmetria, dysdiadokokinesia).
• Cognitive dysfunction as evidenced by a score of less than ??? on the ???

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Multiple Sclerosis; Tremor

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ilana Schlesinger, M.D.

CONTACT

97247771495; movement@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 25, 2015

Record last verified: 2015-11