Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01016743
Status:
UNKNOWN
Last Update Posted:
2009-11-19
First Post:
2009-11-18
Brief Title:
The Influence of Low Frequency Repetitive Transcranial Stimulation r-TMS on Motor and Cognitive Measurements in Patients With Asymmetric Parkinsons Disease
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-11
Last Known Status:
NOT_YET_RECRUITING
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:
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 Parkinsons 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
Detailed Description:
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 will be recruited Participants on antidepressants should be at least 2 months on stable therapy
Patient will be excluded if
1 They have concomitant epilepsy a history of seizure or heat convulsion or history of epilepsy in first degree relative
2 Are on neuroleptics
3 Have dementia or any unstable medical disorder
4 Have a history or current unstable hypertension
5 Have a history of head injury or neurosurgical interventions
6 Have a history of any metal in the head outside the mouth
7 Have a known history of any metallic particles in the eye implanted cardiac pacemaker implanted neurostimulators surgical clips above the shoulder line or any medical pumps
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
The following outcome measures will be taken prior to the treatment screening visit and at day 1 10 30 and 60 Evaluation will be while subjects both at on and off
Motor
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
1 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
8Have a history of migraine or frequent or severe headaches 9Have a history of hearing loss 10Has a of cochlear implants 11Have a history of drug abuse or alcoholism 12Is pregnant or not using a reliable method of birth control 13Is participating in current clinical study or clinical study within 30 days prior to this study
Patient will be excluded if
1 They have concomitant epilepsy a history of seizure or heat convulsion or history of epilepsy in first degree relative
2 Are on neuroleptics
3 Have dementia or any unstable medical disorder
4 Have a history or current unstable hypertension
5 Have a history of head injury or neurosurgical interventions
6 Have a history of any metal in the head outside the mouth
7 Have a known history of any metallic particles in the eye implanted cardiac pacemaker implanted neurostimulators surgical clips above the shoulder line or any medical pumps
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
The following outcome measures will be taken prior to the treatment screening visit and at day 1 10 30 and 60 Evaluation will be while subjects both at on and off
Motor
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
1 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
8Have a history of migraine or frequent or severe headaches 9Have a history of hearing loss 10Has a of cochlear implants 11Have a history of drug abuse or alcoholism 12Is pregnant or not using a reliable method of birth control 13Is participating in current clinical study or clinical study within 30 days prior to this study
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