Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354133
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2006-07-19
Brief Title:
Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinsons Disease
Sponsor:
German Parkinson Study Group GPS
Organization:
German Parkinson Study Group GPS
Study Overview
Official Title:
The Effect of Deep Brain Stimulation of the Subthalamic Nucleus STN-DBS on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinsons Disease and Preserved Psychosocial Competence EARLYSTIM-study
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
ACTIVE_NOT_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:
EARLYSTIM
Brief Summary:
Earlystim Study Patients are randomized either to medical treatment or subthalamic stimulation The observation period was 2 years The primary outcome criterium PDQ-39
Post study Follow up studies After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages or drawbacks compared to later stimulation
Post study Follow up studies After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages or drawbacks compared to later stimulation
Detailed Description:
Parkinsons disease is one of the most disabling chronic neurological diseases It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesias develop The quality of life and the social and occupational functioning is relentlessly deteriorating with longer disease duration once the complications of conservative therapy develop High-frequency stimulation of the subthalamic nucleus especially improves the motor complications of Parkinsons disease and preliminary data suggest that also the quality of life and psychosocial handicap are improved So far this therapy is only used for patients which have already undergone personal professional and social degradation due to motor complications of the disease The aim of this study is to assess the use of this therapy in earlier stages of the disease when motor complications have just developed and before patients are significantly affected in their social and occupational functioning
The main study Earlystim was finished in March 2012 and published in February 2013 Schuepbach WM Rau J Knudsen K et al Neurostimulation for Parkinsons disease with early motor complications N Engl J Med Feb 14 20133687610-622 Patients who were treated with BMT only in the Earlystim Study were privileged to be operated after the 24 months and a follow up phase of 5 years was planned to elucidate whether earlier stimulation has advantages or drawbacks compared to later stimulation
As operated patients fare better in terms of quality of life and other outcomes see publication it will be important to know if patients who are operated earlier keep an advantage in all thoses parameters over those who were operated later or if those operated later will catch up after surgery Also the pattern of adverse events among earlier and later operated patients may differ These issues can be addressed with the post-study follow-up PSFU studies of the patients of the Earlystim trial The results of these investigations elucidate longterm issues of DBS in PD and may affect the recommendations of surgery for patients
The main study Earlystim was finished in March 2012 and published in February 2013 Schuepbach WM Rau J Knudsen K et al Neurostimulation for Parkinsons disease with early motor complications N Engl J Med Feb 14 20133687610-622 Patients who were treated with BMT only in the Earlystim Study were privileged to be operated after the 24 months and a follow up phase of 5 years was planned to elucidate whether earlier stimulation has advantages or drawbacks compared to later stimulation
As operated patients fare better in terms of quality of life and other outcomes see publication it will be important to know if patients who are operated earlier keep an advantage in all thoses parameters over those who were operated later or if those operated later will catch up after surgery Also the pattern of adverse events among earlier and later operated patients may differ These issues can be addressed with the post-study follow-up PSFU studies of the patients of the Earlystim trial The results of these investigations elucidate longterm issues of DBS in PD and may affect the recommendations of surgery for patients
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