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

NCT ID: NCT02249715

Last Updated: 2014-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30

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.

Conditions

Parkinson

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rDTMS

Group Type: EXPERIMENTAL

Brainsway Multiway deep TMS device (two channels)

Intervention Type: DEVICE

Interventions

Brainsway Multiway deep TMS device (two channels)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: collaborator

ElMindA Ltd

INDUSTRY

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Oren Cohen, M.D

Role: CONTACT

Oren.Cohen@sheba.health.gov.il

972-3-5305296

Other Identifiers

SHEBA-1293-14-OC-CTIL

Identifier Type: -

Identifier Source: org_study_id