Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524505
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Efficacy Tolerability and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Tolerability and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression a Double-blind Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation dTMS as an add-on treatment for bipolar depression Meanwhile we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients we hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder
Detailed Description:
This is a randomized double-blind sham-controlled study to detect the effect of dTMS for treatment of bipolar depression 100 participants were randomly assigned 11 to dTMS group or sham-control group For both active and sham group daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks and each session lasted 20minutes Based on the original and stable medication the active stimulation consisted of 55 18 Hz 2 s trains at 120 MT intensity with a between-train interval of 20 s 1980 pulses per day or 39 600 pulses per treatment The sham stimulation was performed using the same procedures with the sham coil
Scale assessments are performed at baseline week 2 week 4 and week 8 Collection of blood took place at baseline week 4 and week 8
Scale assessments are performed at baseline week 2 week 4 and week 8 Collection of blood took place at baseline week 4 and week 8
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