Back to results

MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

MRI guided focused ultrasound thalamotomy

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Tremor, Thalamotomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 ???

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI guided Focused Ultrasound treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tremor rating scale

Tremor Rating Scale

Full Information

NCT ID

NCT02614989

First Posted

November 23, 2015

Last Updated

November 24, 2015

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT02614989

Brief Title

MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis

Official Title

MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This study is designed as a prospective, single site, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of multiple sclerosis patients with severe medication refractory tremor. This study will be performed on the 3T MR scanners. The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. During MRgFUS a pulse of focused ultrasound energy, or sonication,are delivered to the targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion created in the ventralis intermedius nucleus of the thalamus. The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop. MRgFUS uses a transcranial operated helmet-shaped transducer positioned above the subject head. The transcranial system includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation. MRgFUS transcranial system to relieve tremor in multiple sclerosis patients is being investigated in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Tremor, Thalamotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI guided Focused Ultrasound treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

MRI guided focused ultrasound thalamotomy

Intervention Description

MRI guided focused ultrasound thalamotomy

Primary Outcome Measure Information:

Title

Device or procedure related adverse events reported

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Tremor rating scale

Description

Tremor Rating Scale

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 ???

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilana Schlesinger, M.D.

Phone

97247771495

movement@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis

We'll reach out to this number within 24 hrs