Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01367782
Status:
UNKNOWN
Last Update Posted:
2014-09-11
First Post:
2011-05-30
Brief Title:
A Double Blind Sham-controled Study to Evaluate 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:
A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation r-TMS on Motor and Cognitive Measurements in Patients With Asymmetric Parkinsons Disease
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
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:
The purpose of this 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 asymmetric Parkinsons disease PD to establish its safety in this population and to test effects of maintenance treatments
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 Patients who have concomitant epilepsy a history of seizure or heat convulsion or history of epilepsy in first degree relative
2 Patients on neuroleptics
3 Patients with unstable medical disorder
4 History or current unstable hypertension
5 History of head injury or neurosurgical interventions
6 History of any metal in the head outside the mouth
7 Known history of any metallic particles in the eye implanted cardiac pacemaker implanted neurostimulators surgical clips above the shoulder line or any medical pumps
8 History of migraine or frequent or severe headaches
9 Current hearing loss
10 The presence of cochlear implants
11 Current drug abuse or alcoholism
12 Pregnancy or not using a reliable method of birth control
13 Participation in current clinical study or clinical study within 30 days prior to this study
Patients will be to randomized to an active rTMS arm or to a sham stimulation arm Each patient will be given 12 stimulation sessions over a period of 4 weeks and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks
Active treatment with the H-coil will include stimulation over the motor cortex 1 Hz stimulation 110 of the motor threshold for 15 minutes and over the prefrontal cortex 10Hz stimulation 100 of the motor threshold 2 seconds each train 20 seconds between trains for 15 minutes The control arm group will receive sham stimulations in identical treatment and maintenance schedules Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group
The following outcome measures will be taken prior to the treatment screening visit and at day 1 10 30 60 and 90 Evaluation will be while subjects are 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
Patient will be excluded if
1 Patients who have concomitant epilepsy a history of seizure or heat convulsion or history of epilepsy in first degree relative
2 Patients on neuroleptics
3 Patients with unstable medical disorder
4 History or current unstable hypertension
5 History of head injury or neurosurgical interventions
6 History of any metal in the head outside the mouth
7 Known history of any metallic particles in the eye implanted cardiac pacemaker implanted neurostimulators surgical clips above the shoulder line or any medical pumps
8 History of migraine or frequent or severe headaches
9 Current hearing loss
10 The presence of cochlear implants
11 Current drug abuse or alcoholism
12 Pregnancy or not using a reliable method of birth control
13 Participation in current clinical study or clinical study within 30 days prior to this study
Patients will be to randomized to an active rTMS arm or to a sham stimulation arm Each patient will be given 12 stimulation sessions over a period of 4 weeks and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks
Active treatment with the H-coil will include stimulation over the motor cortex 1 Hz stimulation 110 of the motor threshold for 15 minutes and over the prefrontal cortex 10Hz stimulation 100 of the motor threshold 2 seconds each train 20 seconds between trains for 15 minutes The control arm group will receive sham stimulations in identical treatment and maintenance schedules Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group
The following outcome measures will be taken prior to the treatment screening visit and at day 1 10 30 60 and 90 Evaluation will be while subjects are 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
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