Back to resultsDevelopment 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
Primary Purpose
Parkinson
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brainsway Multiway deep TMS device (two channels)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson focused on measuring Parkinson, TMS, BNA
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD patients aged 40-75 years;
- Hoehn and Yahr stages II to IV
- Patients on stable antiparkinsonian therapy for 1 month
- Right hand dominance with right afflicted side.
Exclusion Criteria:
- Participation in current clinical study or clinical study within 30 days prior to this study.
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease)
- Patients with significant psychiatric symptoms or history.
- Patients with psychotic symptoms or active depressive symptoms
- Treatment with neuroleptics.
- Beck depression inventory (BDI) score <14
- Mini Mental status examination (MMSE) score <25
- History of migraine or frequent or severe headaches.
- Significant sensory deficits, e.g., deafness or blindness History of head injury or neurosurgical interventions.
- Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative.
- History of any metal in the head (outside the mouth).
- The presence of cochlear implants
- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- Subjects with an unstable medical disorder.
- Current drug abuse (including Cannabis) or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Patients with severe tremor or dyskinesia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rDTMS
Arm Description
Outcomes
Primary Outcome Measures
Unified Parkinson's Disease Rating Scale (UPDRS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02249715
First Posted
September 23, 2014
Last Updated
September 23, 2014
Sponsor
Sheba Medical Center
Collaborators
Brainsway, ElMindA Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02249715
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
Brainsway, ElMindA Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Parkinson, TMS, BNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rDTMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Brainsway Multiway deep TMS device (two channels)
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic PD patients aged 40-75 years;
Hoehn and Yahr stages II to IV
Patients on stable antiparkinsonian therapy for 1 month
Right hand dominance with right afflicted side.
Exclusion Criteria:
Participation in current clinical study or clinical study within 30 days prior to this study.
Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease)
Patients with significant psychiatric symptoms or history.
Patients with psychotic symptoms or active depressive symptoms
Treatment with neuroleptics.
Beck depression inventory (BDI) score <14
Mini Mental status examination (MMSE) score <25
History of migraine or frequent or severe headaches.
Significant sensory deficits, e.g., deafness or blindness History of head injury or neurosurgical interventions.
Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative.
History of any metal in the head (outside the mouth).
The presence of cochlear implants
Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
Subjects with an unstable medical disorder.
Current drug abuse (including Cannabis) or alcoholism.
Pregnancy or not using a reliable method of birth control.
Patients with severe tremor or dyskinesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Cohen, M.D
Phone
972-3-5305296
Email
Oren.Cohen@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs