Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029276
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-09
Brief Title:
Magnetic Stimulation for Parkinson Disease
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Transcranial Magnetic Stimulation For Treatment Of Depression In Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2006-08
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:
During transcranial magnetic stimulation TMS a magnetic coil is placed on the front part of the head Electric current passes through the coil in brief pulses Magnetism from the current produces a separate small electric current inside the brain which activates brain cells below the coil This treatment may result in decreased depression and improved Parkinsons disease symptoms
Detailed Description:
The major aim of this study is to carry out a sequential Phase I trial of prefrontal transcranial magnetic brain stimulation TMS and electroconvulsive therapy ECT in patients with Parkinsons disease PD and severe depression Depression complicates PD in up to 50 of cases leading to further deterioration of motor performance and quality of life but antidepressant medication fails or produces intolerable side effects in 25-30 of patients Case reports and uncontrolled trials suggest that ECT is effective in ameliorating simultaneously the mood and motor symptoms of PD Only a few small studies of ECT in PD have been prospective or randomized the assessment protocols have been limited and the results have been variable TMS is a new promising alternative treatment for refractory depression which appears to be easier and safer than ECT Requiring no hospitalization anesthesia or recovery time TMS is now being investigated as an alternative therapy for mood disorders TMS has not been studied in depressed patients with PD or in other serious central nervous system diseases
This study extends our past and present research in PD depression ECT and TMS We will comprehensively evaluate the effects of left prefrontal TMS on mood motor and neuropsychological function together with quality of life indices in depressed PD patients All patients will initially receive treatment with TMS Those who fail to benefit will proceed to ECT Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups The key issues addressed by these studies include 1 the potential benefit of TMS on mood and movement in depressed PD patients and 2 the tightness of the association between mood and motor function after TMS and ECT Overall these studies will provide important preliminary data on the relationships among mood cognitive and motor function in PD and their influence on quality of life The results will help in directing future applications of TMS as an alternative therapy for brain disorders and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients A positive effect from TMS should be an impetus towards randomized placebo-controlled trials
This study extends our past and present research in PD depression ECT and TMS We will comprehensively evaluate the effects of left prefrontal TMS on mood motor and neuropsychological function together with quality of life indices in depressed PD patients All patients will initially receive treatment with TMS Those who fail to benefit will proceed to ECT Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups The key issues addressed by these studies include 1 the potential benefit of TMS on mood and movement in depressed PD patients and 2 the tightness of the association between mood and motor function after TMS and ECT Overall these studies will provide important preliminary data on the relationships among mood cognitive and motor function in PD and their influence on quality of life The results will help in directing future applications of TMS as an alternative therapy for brain disorders and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients A positive effect from TMS should be an impetus towards randomized placebo-controlled trials
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