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

NCT00858546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-10-16

No results posted yet for this study

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. 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

Conditions

Interventions

DEVICE

Repetitive transcranial stimulation

Repetitive transcranial stimulation

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858546 on ClinicalTrials.gov