Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-01
Brief Title:
Low Voltage Electrical Stimulation for Depression in Parkinsons Patients
Sponsor:
University of South Alabama
Organization:
University of South Alabama
Study Overview
Official Title:
The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinsons Disease and Controls
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
LVESDIPP
Brief Summary:
The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation mgTDCS in improving the depressive symptoms of patients with Parkinsons Disease PD The main questions it aims to answer are 1 Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control 2 Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS 3 Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory
Detailed Description:
This study seeks to expand the growing body of literature on the use of a particular type of low voltage electrical stimulation known as Transcranial Direct Current Stimulation TDCS to reduce the symptoms of Parkinsons Disease PD One common disorder that can result from andor be exacerbated by PD is Major Depressive Disorder In particular apathy has been noted as a common and detrimental component for those with PD While many studies have been performed on PD patients using TDCS the consensus in the literature is that results are widely variable
Participants will
complete self-report measures and neuropsychological tests
undergo eeg recording pre and post intervention
participate in 15 46 minute sessions 2 13 minute stimulation sessions with 20 minutes of rest between of mgTDCS over the course of 4-5 weeks Researchers will compare active mgTDCS to Sham mgTDCS to see if active mgTDCS is more effective A non Parkinsons group of depressed controls who are age-matched to the PD patients will serve to determine if treatment effects are specific to PD or generalize to depression more generally
Participants will
complete self-report measures and neuropsychological tests
undergo eeg recording pre and post intervention
participate in 15 46 minute sessions 2 13 minute stimulation sessions with 20 minutes of rest between of mgTDCS over the course of 4-5 weeks Researchers will compare active mgTDCS to Sham mgTDCS to see if active mgTDCS is more effective A non Parkinsons group of depressed controls who are age-matched to the PD patients will serve to determine if treatment effects are specific to PD or generalize to depression more generally
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?:
None
Is an FDA AA801 Violation?:
None