Ignite Creation Date:
2024-05-05 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00577070
Status:
COMPLETED
Last Update Posted:
2009-10-06
First Post:
2007-12-18
Brief Title:
Evaluation of the H-Coil Transcranial Magnetic StimulationTMS Device- Augmentation for Drug Resistant Depression
Sponsor:
BeerYaakov Mental Health Center
Organization:
BeerYaakov Mental Health Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-01
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:
There is a general consensus of efficacy of TMS in treatment of major depressionyet results are not satisfyingA new coil H-coil recently invented in Weizmann Institute of Science Neurobiology Department Rehovot Israel is supposed to be capable of stimulating deeper brain structures than conventional coilsTMS using this coil was named by its developers as deep TMS and will hence be refered to by this name
So far deep TMS have studied in Israel with promising sucssess in patients with Major depression An on-going studyA safety study with good results have been recently publishedThe aim of this study is to reinforce initial results in major depression using deep TMS
So far deep TMS have studied in Israel with promising sucssess in patients with Major depression An on-going studyA safety study with good results have been recently publishedThe aim of this study is to reinforce initial results in major depression using deep TMS
Detailed Description:
A group of 40 patients with major depression will be randomly assigned to deep TMS with H-1 coil in frequency of 20 HZ or H-2 coil in frequency of 01 HZ with 120 of motor threshold to the prefrontal cortex No change in anti-depressant medication one month prior to study is a prerequisiteDeep TMS will be administered for 4 weeksDuring TMS exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminationsPatients will be evaluated using Hamilton Depression Rating Scale HAM-D24Hamilton Anxiety Rating Scale HAM-AClinical Global Impression - ImprovementCGI-I Beck Depression Inventory BDIVisual Analog Scale VAS
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