Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03648268
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2018-08-21
Brief Title:
Using Transcranial Magnetic Stimulation TMS to Understand Negative Symptoms of Schizophrenia
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Network Mediation of Experiential and Expressive Deficits in Psychotic Disorders
Status:
COMPLETED
Status Verified Date:
2024-03
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 main purpose of this study is to learn how transcranial magnetic stimulation TMS helps improve negative symptoms of schizophrenia These negative symptoms include anhedonia the inability to enjoy things low motivation and decreased facial expression
TMS is a noninvasive way of stimulating the brain TMS uses a magnetic field to cause changes in activity in the brain The magnetic field is produced by a coil that is held next to the scalp In this study we will be stimulating the brain to learn more about how TMS may improve these symptoms from schizophrenia
TMS is a noninvasive way of stimulating the brain TMS uses a magnetic field to cause changes in activity in the brain The magnetic field is produced by a coil that is held next to the scalp In this study we will be stimulating the brain to learn more about how TMS may improve these symptoms from schizophrenia
Detailed Description:
This study proposes to test the hypothesis that the medication refractory experiential anhedonia and amotivation and expressive deficits named negative symptoms are mediated by network pathophysiology and the functional connectivity of a cerebellar-prefrontal cortical network mediates the severity of these deficits To accomplish this participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who demonstrate negative symptoms despite stable outpatient treatment
Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of negative symptom severity These assessments include reporter-based measures such as the Positive And Negative Syndrome Scale PANSS as well as quantitative tests of amotivationanhedonia and diminished expressivity
Participants will then undergo an MRI scan that includes structural and resting state functional magnetic resonance imaging rsfMRI These rsfMRI images will be used to isolate individual resting-state networks for targeting of rTMS modulation
Participants will then undergo five days of twice daily rTMS sessions in one of the four arms of this study
One week after the last rTMS session Participants will undergo follow-up MRI imaging and the same assessments described above
Aims
Aim 1 To determine if network dysconnectivity is causally linked to negative symptom severity and if amelioration of this dysconnectivity results in reduced symptom severity Symptom severity will be measured via both reporter-based and quantitative measures
Aim 2 To determine if the relationship between functional connectivity and symptom severity arises from interactions between specific nodes of the default mode network DMN the cerebellum and DLPFC or is the result of interactions between multiple nodes in the DMN both cerebral and cerebellar
Exploratory Aim As an exploratory aim additional genetic data will be collected which may be related to TMS efficacy Hypothesis Brain-derived neurotrophic factor BDNF homozygous val-allele carriers of the val66met BDNF gene will show greater response than met-carriers
Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of negative symptom severity These assessments include reporter-based measures such as the Positive And Negative Syndrome Scale PANSS as well as quantitative tests of amotivationanhedonia and diminished expressivity
Participants will then undergo an MRI scan that includes structural and resting state functional magnetic resonance imaging rsfMRI These rsfMRI images will be used to isolate individual resting-state networks for targeting of rTMS modulation
Participants will then undergo five days of twice daily rTMS sessions in one of the four arms of this study
One week after the last rTMS session Participants will undergo follow-up MRI imaging and the same assessments described above
Aims
Aim 1 To determine if network dysconnectivity is causally linked to negative symptom severity and if amelioration of this dysconnectivity results in reduced symptom severity Symptom severity will be measured via both reporter-based and quantitative measures
Aim 2 To determine if the relationship between functional connectivity and symptom severity arises from interactions between specific nodes of the default mode network DMN the cerebellum and DLPFC or is the result of interactions between multiple nodes in the DMN both cerebral and cerebellar
Exploratory Aim As an exploratory aim additional genetic data will be collected which may be related to TMS efficacy Hypothesis Brain-derived neurotrophic factor BDNF homozygous val-allele carriers of the val66met BDNF gene will show greater response than met-carriers
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