Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00858546
Status:
COMPLETED
Last Update Posted:
2009-10-16
First Post:
2009-03-08
Brief Title:
The Influence of Low Frequency Repetitive Transcranial Stimulation r-TMS Treatment on Motor and Cognitive Measurements in Patients With Parkinsons Disease
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
The Influence of Low Frequency Repetitive Transcranial Stimulation r-TMS Treatment on Motor and Cognitive Measurements in Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 Parkinsons 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
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 Parkinsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None