Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04455646
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-06-29
Brief Title:
Combining H1-Coil Deep Transcranial Magnetic Stimulation dTMS and App-guided CBT in Subjects With Major Depression Disorder MDD
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
Combining H1-Coil Deep Transcranial Magnetic Stimulation dTMS and App-guided CBT in Subjects With Major Depression Disorder MDD
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
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:
None
Brief Summary:
A naturalistic study design in which dTMS patients will be randomized to get a free add-on CBT treatment The dTMS procedure will include treatment as usual and participants will use the app from post randomization Pre-treatment is defined as measures from the first three days of treatment to the end of dTMS treatment Post-treatment which is defined as measures from after twenty TMS sessions over a minimum of four weeks and for an additional three months of FU FU
Detailed Description:
Participants will be recruited from those attending dTMS clinics around the world ienaturalistic study design and consenting individuals in person consent done in the clinic on paper will be given a random user code This code will be specific for their version of the app and the only link between their signature and the code will remain at the site for auditing purposes Participants will undergo treatment as usual of dTMS and will use GGDE twice a day Participants will be asked to complete demographic and clinical questionnaires via the GGDE app and relevant clinical questionnaires will be re-administered following treatment and during FU The initial and all following dTMS sessions will involve patients going through the stimulation procedure The operator will record stimulation variables such as individual patients intensity of stimulation and coil location into GGDE followed by 5 min of GGDE use The patient will indicate which statements in that session were most relevant and challenging to them which will be followed by a pre-prepared psycho-education paragraph about the specific maladaptive belief addressed by the app that day The patient will then be prompted to use the app one more time at home during the same day Patient will continue similar use during FU with two GGDE usage each day The naturalistic design will allow the accumulation of large quantities of data in a short period of time aiming to optimize GGDE using machine learning Importantly GGDE will allow the random allocation of users to different GGDE modules of the app ie similar app versions with changes in specific parameters related to different depressive traits One out of the ten modules used in this trial will include neutral placebo stimuli requiring the user to respond to plusminus signs rather than MDD relevant statements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None