NCT00858546

Brief Summary

The aim of the 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 Parkinson's disease (PD) and to establish its safety in this population. The investigators anticipate to recruit 10 patients to an open pilot study. All patients will receive an active rTMS stimulation and will be given 12 treatment sessions, over a period of up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes each), will be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2 seconds each with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz over the the motor cortex. The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60, and 90:

  1. 1.Unified Parkinson's Disease Rating Scale (UPDRS )
  2. 2.Clinical Global Impression of Severity (CGIS)
  3. 3.Pegboard test.
  4. 4.Tapping test
  5. 5.Up \& Go test
  6. 6.Abnormal Involuntary Movement Scale (AIMS) Mood and affect Beck Depression Inventory (BDI) Cognition

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

March 8, 2009

Last Update Submit

October 15, 2009

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS )

    1 year

Secondary Outcomes (1)

  • CGIS, Pegboard test,Tapping test,Up & Go test, AIMS,BDI MMSE, Digit forward and backward, Word fluency, FAB

    1 year

Study Arms (1)

Active repetitive transcranial Stimulation

EXPERIMENTAL

Active repetitive transcranial Stimulation

Device: Repetitive transcranial stimulation

Interventions

Repetitive transcranial stimulationDEVICE

Repetitive transcranial stimulation

Active repetitive transcranial Stimulation

Eligibility Criteria

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

You may qualify if:

  • PD patients 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 dementia or any 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 or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  • History of migraine or frequent or severe headaches.
  • History of hearing loss.
  • The presence of cochlear implants
  • History of 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

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

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

Study Record Dates

First Submitted

March 8, 2009

First Posted

March 10, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

IL(1)