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

Parkinson Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02249715
• Other study ID #: SHEBA-1293-14-OC-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2014
• Last updated: September 23, 2014
• Start date: November 2014

Study information

• Verified date: September 2014
• Source: Sheba Medical Center
• Contact: Oren Cohen, M.D
• Phone: 972-3-5305296
• Email: Oren.Cohen[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Device:
• Brainsway Multiway deep TMS device (two channels)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	Brainsway, ElMindA Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS)		3 month	No