Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248768
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2005-11-02
Brief Title:
Accelerated Transcranial Magnetic Stimulation TMS for Depression
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Accelerated Transcranial Magnetic Stimulation for Depression
Status:
COMPLETED
Status Verified Date:
2014-09
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:
ATMS
Brief Summary:
The purpose of this study is to determinate if accelerated rTMS treatment over 15 days is effective for ameliorating depression in Parkinsons disease
Detailed Description:
Objective The goal of this study is to investigate a new approach to administering repetitive transcranial magnetic stimulation rTMS in patients with refractory depression Please Note The original requirement for comorbid Parkinsons disease has been dropped from this study
Research Plan This inpatient study will provide an initial test for the hypothesis that accelerated rTMS is an effective treatment for depression Followup testing will help delineate the time course of response
Methods The rTMS treatment site over left dorsolateral prefrontal cortex will be 55cm anterior to the hand motor area Treatments consisting of 1000 total pulses at 10 Hz and 100 motor threshold will be administered hourly for 15 days totaling 15 sessions A comprehensive test battery will be administered just before and after treatment at 3 weeks and at 6 weeks after treatment
Clinical Relevance We expect that accelerated rTMS treatments will lessen the degree of depression to the same extent as rTMS treatments of longer duration but far more rapidly A much shorter hospitalization would be more easily tolerated In addition reducing the duration of hospitalization substantially reduces burdens and costs to hospital staff and caregivers while more rapidly enhancing function and quality of life
Research Plan This inpatient study will provide an initial test for the hypothesis that accelerated rTMS is an effective treatment for depression Followup testing will help delineate the time course of response
Methods The rTMS treatment site over left dorsolateral prefrontal cortex will be 55cm anterior to the hand motor area Treatments consisting of 1000 total pulses at 10 Hz and 100 motor threshold will be administered hourly for 15 days totaling 15 sessions A comprehensive test battery will be administered just before and after treatment at 3 weeks and at 6 weeks after treatment
Clinical Relevance We expect that accelerated rTMS treatments will lessen the degree of depression to the same extent as rTMS treatments of longer duration but far more rapidly A much shorter hospitalization would be more easily tolerated In addition reducing the duration of hospitalization substantially reduces burdens and costs to hospital staff and caregivers while more rapidly enhancing function and quality of life
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Emory IRB 601-2004 | OTHER | Emory IRB | None |