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

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

1. Mini mental State examination (MMSE) 2. Digit forward and backward tests. 3. Word fluency. 4. Frontal Assessment Battery (FAB)

Side effects will be closely monitored by the researchers and will be promptly reported to the IRB

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, 52621, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Repetitive transcranial stimulation

Device

Repetitive transcranial stimulation

Primary outcomes

Unified Parkinson's Disease Rating Scale (UPDRS )

Time frame: 1 year

Secondary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 10, 2009
Registry last updated: Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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