Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869708
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-04-23
Brief Title:
PRISM Neurofeedback Training for MDD Anhedonic Patients
Sponsor:
GrayMatters Health Ltd
Organization:
GrayMatters Health Ltd
Study Overview
Official Title:
Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder MDD With Anhedonia Using Clinical Biomarkers for MDD Subtypes
Status:
RECRUITING
Status Verified Date:
2024-04
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 goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample
The goals of this study include
1 Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample
2 Identifying clinical profilesymptoms-based biomarkers eg Hamilton Depression Rating Scale - HDRS-21 Dimensional Anhedonia Rating Scale - DARS Snaith-Hamilton Pleasure Scale for Clinicians SHAPS scores that can be used by clinics to administer Prism therapy in conjunction with standard of care SOC therapy
3 Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia SOC
Participants will be randomly assigned to one of two arms Active or Sham
The goals of this study include
1 Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample
2 Identifying clinical profilesymptoms-based biomarkers eg Hamilton Depression Rating Scale - HDRS-21 Dimensional Anhedonia Rating Scale - DARS Snaith-Hamilton Pleasure Scale for Clinicians SHAPS scores that can be used by clinics to administer Prism therapy in conjunction with standard of care SOC therapy
3 Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia SOC
Participants will be randomly assigned to one of two arms Active or Sham
Detailed Description:
During the study participants will perform the following
Complete clinical assessments using questionnaires an MRI scan and tasks that probe reward responsivity learning and motivation
Perform at least 10 sessions but optimally 15 -3 neurofeedback training sessions performed twice a week on nonconsecutive days for 5-8 weeks
Complete the same clinical assessments post-NF training MRI scan and tasks same as in the screeningbaseline stage
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia
Complete clinical assessments using questionnaires an MRI scan and tasks that probe reward responsivity learning and motivation
Perform at least 10 sessions but optimally 15 -3 neurofeedback training sessions performed twice a week on nonconsecutive days for 5-8 weeks
Complete the same clinical assessments post-NF training MRI scan and tasks same as in the screeningbaseline stage
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia
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?:
False
Is an FDA AA801 Violation?:
None