Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236711
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-11
Brief Title:
Transcranial Direct Current Stimulation tDCS As an Adjunctive Treatment for Treatment Resistant Depression TRD
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Feasibility Study of Transcranial Direct Current Stimulation tDCS As an Adjunctive Treatment for Treatment Resistant Depression TRD in Hospitalized Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation tDCS in hospitalized adult patients with Treatment Resistant Depression TRD assess for any preliminary effect on depressive and cognitive symptoms and explore the utility of biomarkers to assess response to tDCS
Detailed Description:
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD with each treatment session lasting for 30 minutes delivered twice daily for a total of 10 stimulations over 5 days Before and after the 5-day tDCS treatment protocol assessments will include Montgomery-Asberg Depression Rating Scale MADRS to measure depressive symptoms Snaith-Hamilton Pleasure Scale SHAPS to measure anhedonia Stroop Test to measure memory and executive function Revised Hopkins Verbal Learning Test HVLT-R to test verbal learning and memory and Digital Symbol Coding Test DSCT to measure working memory Electroencephalography EEG for objective electrophysiologic data will also be collected before and after tDCS A wireless EEG unit CGX Cognionic Inc will be used to collect EEG and peak alpha frequency PAF as potential target engagement marker for tDCS The PAF measures the highest magnitude within the alpha range of brain oscillations thought to reflect cognitive performance Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences ACE premorbid intelligence quotient pIQ Wide Range Achievement Reading Test WRART and Socioeconomic Status SES
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?:
None
Is an FDA AA801 Violation?:
None