The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

NCT01016743 | Unknown

• 1 other identifier: SHEBA-09-7279-OC-CTIL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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) and to establish its safety in this population. The investigators anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.

Conditions

UPDRS

Keywords

parkinson; rTMS

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (UPDRS )

  1 year

Secondary Outcomes (2)

• CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB

  1 year

• UPDRS

  3 months

Study Arms (1)

Active repetitive transcranial Stimulation

ACTIVE COMPARATOR

Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Device: repetitive transcranial stimulation (r-TMS)

Interventions

repetitive transcranial stimulation (r-TMS) DEVICE

Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Active repetitive transcranial Stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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).

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Design

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

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Last Updated: November 19, 2009

Record last verified: 2009-11