NCT01367782

Brief Summary

The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

3.6 years

First QC Date

May 30, 2011

Last Update Submit

September 10, 2014

Conditions

Asymmetric Parkinson's Disease

Keywords

UPDRS

Outcome Measures

Primary Outcomes (1)

  • Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score

    A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score.

    3 months

Secondary Outcomes (7)

  • CGIS

    3 months

  • Decrease in time in Pegboard test

    3 months

  • Increase in Tapping test

    3 months

  • Decrease in Time Up&Go test

    3 months

  • Increase in Word fluency

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Active repetitive Transcranial Stimulation

ACTIVE COMPARATOR

Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.

Device: repetitive transcranial stimulation (r-TMS)

Sham Stimulation

SHAM COMPARATOR

The control arm group will receive sham stimulations in identical treatment and maintenance schedules.

Device: repetitive transcranial stimulation (r-TMS)

Interventions

repetitive transcranial stimulation (r-TMS)DEVICE

Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Active repetitive Transcranial Stimulation

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off".
  • Participants on antidepressants should be at least 2 months on stable therapy.

You may not qualify if:

  • Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  • Patients on neuroleptics.
  • Patients with unstable medical disorder.
  • History or current unstable hypertension.
  • History of head injury or neurosurgical interventions.
  • History of any metal in the head (outside the mouth).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  • History of migraine or frequent or severe headaches.
  • Current hearing loss.
  • The presence of cochlear implants
  • Current drug abuse or alcoholism.
  • Pregnancy or not using a reliable method of birth control.
  • Participation in current clinical study or clinical study within 30 days prior to this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Study Officials

  • Oren Cohen, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Cohen, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2011

First Posted

June 7, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

IL(1)