The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease

NCT03300193 | Completed

• 1 other identifier: 0162-15-RMB
• Study Type: observational
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.

Conditions

Tremor

Keywords

Magnetic Resonance guided Focused Ultrasound; Tremor; Essential Tremor; Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Clinical Rating Scale for Tremor

  Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)

  3 MONTHS

• Motor part of Unified PD Rating Scale

  In PD patients - Motor part of Unified PD Rating Scale (UPDRS)

  3 MONTHS

Secondary Outcomes (3)

• Quality of Life Essential Tremor Questionnaire

  3 MONTHS

• Parkinson's Disease Questionnaire

  3 MONTHS

• iSeismometer application

  3 MONTHS

Other Outcomes (4)

• adverse events of the MRgFUS

  3 MONTHS

• assessment of the location of lesion on MRI

  3 MONTHS

• Size of the lesion on MRI

  3 MONTHS

Study Arms (1)

Tremor patients

Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.

You may qualify if:

• Men and women, between 18 and 80 years.
• Patients who underwent the MRgFUS procedure.
• Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.
• A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.
• ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).
• PD patients: tremor severity score of equal or greater than 3 on either item 20 or item 21 of motor part in the Unified PD Rating Scale (UPDRS).
• Substantial disability in the performance of at least two daily activities from the disability subsection of the scales UPDRS for PD patients or CRST for ET patients.
• The patient must have a history of an unsatisfactory response to medical management. All patients 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.
• Stable doses of all medications for 30 days prior to study entry.

You may not qualify if:

• Patients which have not completed the MRgFUS procedure.
• Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Tremor; Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Menashe Zaaroor, MD, DSc

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurosurgical Department

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: October 3, 2017
• Study Start: May 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share