Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001545
Status:
COMPLETED
Last Update Posted:
2006-07-13
First Post:
1999-11-03
Brief Title:
Evaluation of Repetitive Transcranial Magnetic Stimulation rTMS in the Treatment of Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of rTMS in the Treatment of Mood Disorders
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This study is designed to evaluate repetitive transcranial magnetic stimulation rTMS as a potential treatment for depression In rTMS a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities or whether you will be randomized to 3 weeks of high frequency 20 cycles er second low frequency 1 cycle per second or inactive shamrTMS You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks Each rTMS treatment session should take between 20-30 minutes of actual stimulation but weekly ratings memory testing and blood sampling may require several hours per week We will also ask you to have brain imaging procedures to see if these will predict response to high vs low frequency rTMS If you are randomized to the 3 weeks of sham rTMS you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments
Detailed Description:
Repetitive transcranial magnetic stimulation rTMS is a new technique for activating the brain noninvasively through the scalp and skull It has proven effective in producing localized effects on brain function and has opened many areas of human brain function to direct investigation Preliminary data also suggest potential therapeutic applications in neuropsychiatric illness We plan to further investigate the possible therapeutic use of rTMS in depression under conditions of high frequency 20 Hz low 1Hz frequency and sham and to also examine possible cognitive or endocrine effects Among the priorities of this protocol will be to further evaluate the risks of the technique
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 |
|---|---|---|---|
| 96-M-0086 | None | None | None |