NCT02249715

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

September 23, 2014

Last Update Submit

September 23, 2014

Conditions

Parkinson

Keywords

ParkinsonTMSBNA

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    3 month

Study Arms (1)

rDTMS

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

Interventions

Brainsway Multiway deep TMS device (two channels)DEVICE
rDTMS

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Oren Cohen, M.D

CONTACT

972-3-5305296Oren.Cohen@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 26, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Last Updated

September 26, 2014

Record last verified: 2014-09