Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease

September 23, 2014 updated by: Sheba Medical Center

Pilot Study for Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease

  • To characterize physiological biomarkers of positive response to rDTMS using EEG and functional MRI (fMRI) in patients with PD.
  • To develop a set-up and algorithm for neurophysiological monitoring for PD patients using EEG and fMRI in patients treated by rDTMS.
  • To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of providing closed-loop feedback where monitoring informs the stimulation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PD Patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria will be treated by an established rDTMS protocol will be monitored before, during and after rDTMS using quantitative EEG and brain network analysis and fMRI while performing a series of cognitive and motor tasks.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Idiopathic PD patients aged 40-75 years;
  2. Hoehn and Yahr stages II to IV
  3. Patients on stable antiparkinsonian therapy for 1 month
  4. Right hand dominance with right afflicted side.

Exclusion Criteria:

  1. Participation in current clinical study or clinical study within 30 days prior to this study.
  2. Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease)
  3. Patients with significant psychiatric symptoms or history.
  4. Patients with psychotic symptoms or active depressive symptoms
  5. Treatment with neuroleptics.
  6. Beck depression inventory (BDI) score <14
  7. Mini Mental status examination (MMSE) score <25
  8. History of migraine or frequent or severe headaches.
  9. Significant sensory deficits, e.g., deafness or blindness History of head injury or neurosurgical interventions.
  10. Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative.
  11. History of any metal in the head (outside the mouth).
  12. The presence of cochlear implants
  13. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  14. Subjects with an unstable medical disorder.
  15. Current drug abuse (including Cannabis) or alcoholism.
  16. Pregnancy or not using a reliable method of birth control.
  17. Patients with severe tremor or dyskinesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rDTMS
Device: Brainsway Multiway deep TMS device (two channels)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

ElMindA Ltd
Brainsway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-1293-14-OC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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