Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132581
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-11-07
Brief Title:
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Status:
RECRUITING
Status Verified Date:
2024-01
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:
DBA
Brief Summary:
Anhedonia the inability to seek-out and experience pleasure is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants In our previous research we found that anhedonia decreases goal-directed behavior and its related neural activity In this study we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia
Detailed Description:
The experiment comprises eight sessions total People that request to be in the experiment will first complete demographic and self-report clinical assessments People that meet our eligibility criteria will be invited to participate in the study In the first session clinical assessment are administered to determine eligibility for the full study In the second session participants complete a functional magnetic resonance imaging MRI session in which they complete three different reward-based decision-making tasks After the MRI session participants are randomized into one of three parallel arms to receive five consecutive days of cross-frequency transcranial alternating current stimulation CF-tACS in either delta-beta control-frequency theta-gamma or placebo sham CF-tACS In the third through seventh session participants receive 40 minutes of CF-tACS while completing goal-setting and action planning worksheets Before the first session of CF-tACS the third session overall and the last session of CF-tACS the seventh session overall participants complete brief self-report clinical assessments On the third and seventh session the first and fifth day of CF-tACS the participant will complete the reward-based decision-making tasks prior to stimulation while EEG is recorded In these two sessions resting-state EEG is acquired before and after stimulation The first and fifth session of tACS third and seventh session overall will take approximately three hours to complete The second through fourth session of tACS fourth through sixth session overall will take approximately one hour to complete In the follow-up session visit 8 approximately two weeks after the end of the five-days of stimulation participants return for an in-person session that includes self-report clinical assessments and EEG during the reward-based decision-making tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R00MH126161-03 | NIH | None | httpsreporternihgovquickSearch4R00MH126161-03 |