Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184165
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-11-20
Brief Title:
Stratifying Psychoses for Personalized REpetitive TMS in Persistent NEgative Symptoms Alleviation
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Stratifying Psychoses for Personalized REpetitive TMS in Persistent NEgative Symptoms Alleviation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
SP-RENESA
Brief Summary:
In its 2012s release guideline on therapy for schizophrenia the EMA joined the FDA to acknowledge primary and persistent negative symptoms PNS as an unmet need in the treatment of schizophrenia Functional brain imaging studies showed a correlation between NS and reduced perfusion in the left dorsolateral prefrontal cortex L-DLPFC Pre-frontal activation PFA using repetitive transcranial magnetic stimulation rTMS significantly improve PNS meta-analyses effect size SMD 055 ΔPANSS-N -25 Yet schizophrenia is likely to gather many different natural entities of distinct pathophysiological mechanisms Pursuing a one-size-fits-all approach will not adapt to this diversity and might account for inconsistencies in the results
Progressive periodic catatonia PPC is a rare psychotic phenotype 01 - 05 which has been shown to be longitudinally stable 30-years follow-up and consistent within families about 1 third of first-degree relatives are affected The core of this phenotype is a disintegration of psychomotor processes which progresses with each relapse resulting in a deficit state ie PNS responsible for most social and occupational disabilities The investigators and others reported PPC to come with hyper-perfusions in premotor cortices compared to controls or non-PPC chronic psychoses nPPC These hyper-perfusions discriminate PPC from nPPC or depressive patients Sensitivity 82 Specificity 95 Last in independent proof-of-principle studies the investigators and others have shown that premotor inhibition PMI using rTMS significantly improved PNS in PPC and that the most dramatic improvements followed personalized accelerated rTMS protocols 5 days of rTMS CGI-improvement 2 which is equivalent to ΔPANSS-N -10 lasting 1 month - vs virtually no change for PFA The efficacy index was very good no side effects
the investigators hypothesize that 1 in PPC add-on personalized premotor inhibition PMI is more effective in reducing PNS than L-DLPFC activation PFA 2 patient stratification is relevant as personalized PMI will not be as effective in the nPPC group even expected to be less effective than PFA
Progressive periodic catatonia PPC is a rare psychotic phenotype 01 - 05 which has been shown to be longitudinally stable 30-years follow-up and consistent within families about 1 third of first-degree relatives are affected The core of this phenotype is a disintegration of psychomotor processes which progresses with each relapse resulting in a deficit state ie PNS responsible for most social and occupational disabilities The investigators and others reported PPC to come with hyper-perfusions in premotor cortices compared to controls or non-PPC chronic psychoses nPPC These hyper-perfusions discriminate PPC from nPPC or depressive patients Sensitivity 82 Specificity 95 Last in independent proof-of-principle studies the investigators and others have shown that premotor inhibition PMI using rTMS significantly improved PNS in PPC and that the most dramatic improvements followed personalized accelerated rTMS protocols 5 days of rTMS CGI-improvement 2 which is equivalent to ΔPANSS-N -10 lasting 1 month - vs virtually no change for PFA The efficacy index was very good no side effects
the investigators hypothesize that 1 in PPC add-on personalized premotor inhibition PMI is more effective in reducing PNS than L-DLPFC activation PFA 2 patient stratification is relevant as personalized PMI will not be as effective in the nPPC group even expected to be less effective than PFA
Detailed Description:
None
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