Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517121
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
tDCS in People With Subthreshold Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness mood and depressiveness in people with subthreshold depression
Detailed Description:
Depression-prone individuals will be invited and allocated to three groups either the personalised transcranial direct current stimulation tDCS group the conventional tDCS group or the sham control group After screening and at baseline prior to the tDCS sessions participants will complete tests and questionnaires on depression symptoms loneliness and mood and they will also receive functional magnetic resonance imaging MRI in a 3-Tesla MRI scanner There will be a total of 10 sessions to be completed after the screening and baseline measures For both personalised tDCS group and the conventional tDCS group tDCS with 2 milliampere mA intensity will be delivered for 20 minutes in each session For sham control group the protocol will be similar except that the stimulation only happens in the first 30 seconds in each session Especially for participants allocated to the personalised tDCS group the stimulation site for each individual in this group may vary depending on their brain activations and connectivity The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC Immediately after and also 3-months after completing the 10 sessions participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood and they will also receive functional MRI scanning in the 3T MRI scanner Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study
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