Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286930
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-01-29
Brief Title:
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder- A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Hypothesis Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies
Primary Outcomes
1 To observe the impacts and outcomes of cerebellar transcranial direct current stimulation tDCS on social behaviors measured by Cyberball and Trust Game
2 To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest ROI of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks
Secondary Outcomes
1To observe the impacts and outcome of cerebellar transcranial direct current stimulation tDCS measuring the differences between anodal and cathodal stimulation To observe potential increases in responses to social stimuli decreases in eating disorderdepressive symptomology via cathodal stimulation To also observe potential little to no changes in social stimuli and eating disorderdepressive symptomology via anodal stimulation
Primary Outcomes
1 To observe the impacts and outcomes of cerebellar transcranial direct current stimulation tDCS on social behaviors measured by Cyberball and Trust Game
2 To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest ROI of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks
Secondary Outcomes
1To observe the impacts and outcome of cerebellar transcranial direct current stimulation tDCS measuring the differences between anodal and cathodal stimulation To observe potential increases in responses to social stimuli decreases in eating disorderdepressive symptomology via cathodal stimulation To also observe potential little to no changes in social stimuli and eating disorderdepressive symptomology via anodal stimulation
Detailed Description:
The study will be randomized single blind design It will involve a group of 15 female participants ranging in the ages of 15-30 years old diagnosed with Anorexia Nervosa Diagnosis will be confirmed by recruitment methods of in-clinic referrals Each participant will undergo the two different electrode stimulations of the tDCS Each participant will get anodal and cathodal stimulation The participants will be unaware of which one they are getting during stimulation but the researcher will be informed of which stimulation is occurring The participant will receive 1mA stimulation of the tDCS for 20 minutes in the MRI scanner After the stimulation is complete in the scanner the participant will be asked to complete tasks in the scanner as well The study involves initial screening to determine eligibility to participate Once eligibility criteria is met the participant will sign consent via DocUSign After this virtual visit is complete the participant will be asked to come in for intake visit At the intake the participant will undergo a series of questionnaires and tasks to complete as part of pre-scanning The next session will be stimulation and MRI imaging Participant will undergo resting state and a structural scan After the scans are complete the participant will receive 20 minutes of tDCS stimulation After the simulation is complete the participant will be asked to engage in tasks in the scanner Finally after the scanning session the participant will come back for a post session that is the same as the intake and undergo questionnaires and tasks to complete After the post session researchers will reach out to participants one week and one month after MRI imaging to go over safety questionnaire of the tDCS The participant will have a total of 5 sessions which may include both in-person andor virtual visits with screening session first session second session one week follow-up session and one-month follow-up session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None