Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134661
Status:
TERMINATED
Last Update Posted:
2024-07-11
First Post:
2023-10-23
Brief Title:
Accelerated rTMS for Psychomotor Slowing
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Optimizing rTMS for Psychomotor Slowing in Psychosis ATMSSlowing - A 1-week Non-randomised Clinical Trial of add-on Accelerated Repetitive Transcranial Magnetic Stimulation for Psychomotor Slowing in Psychosis
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Planned interim analyses demonstrated that the main aim of the study was already met Recruitment was stopped Early termination was unrelated to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATMSSlowing
Brief Summary:
The goal of this clinical trial is to optimize the treatment of psychomotor slowing in patients with schizophrenia using Transcranial Magnetic Stimulation TMS A previous randomized controlled trial indicated that inhibitory stimulation over the supplementary motor area SMA once daily over 3 weeks ameliorates psychomotor slowing In this trial the investigators use a shorter inhibitory protocol called cTBS and to be applied 3 times per day This should lead to faster treatment response and less burden to patients
The main question the investigators aim to answer are
Can the treatment with cTBS 3 times per day ameliorate psychomotor slowing in schizophrenia over one week
Participants will complete questionnaires on the first and last day of the study Each day participants will receive the TMS-treatment Optionally participants can receive a cerebral MRI before the study andor come for an additional day 6 to repeat some of the questionnaires
There is no comparison group All participants will receive the same treatment
The main question the investigators aim to answer are
Can the treatment with cTBS 3 times per day ameliorate psychomotor slowing in schizophrenia over one week
Participants will complete questionnaires on the first and last day of the study Each day participants will receive the TMS-treatment Optionally participants can receive a cerebral MRI before the study andor come for an additional day 6 to repeat some of the questionnaires
There is no comparison group All participants will receive the same treatment
Detailed Description:
Schizophrenia is a chronic disorder causing tremendous burden to the patients families and society Besides prominent symptoms such as hallucinations delusions and thought disorder the majority of patients also experiences motor abnormalities Converging evidence links aberrant structure and function of the cerebral motor network to schizophrenia pathology particularly to motor abnormalities One of the most frequent motor abnormalities is psychomotor slowing PS which may impact both gross and fine motor behaviour While PS causes significant distress and predicts poor outcome researchers are just starting to understand its pathobiology First evidence points to aberrant functional and structural connectivity within the cerebral motor network in schizophrenia patients with PS particularly in connections between premotormotor cortex and thalamus as well as between motor cortex and cerebellum In addition severe motor inhibition was linked to increased neural activity in the premotor cortex Repetitive transcranial magnetic stimulation rTMS may temporarily alter brain activity
Data from OCoPS-P BASEC 2018-02164 clinicaltrialsgov NCT03921450 double-blind RCT indicate that 15 sessions of inhibitory rTMS over three weeks on the supplementary motor area SMA alleviate PS
However three weeks of one daily rTMS session is rather inconvenient for patients and medical professionals Therefore this study will aim to optimize the treatment protocol with regard to efficiency and efficacy by using an accelerated rTMS protocol with continuous theta-burst stimulation cTBS Inhibitory cTBS will be applied 3 times per day over 5 days which will increase the session frequency and shorten sessions and treatment duration
Reducing the duration of the treatment phase might increase treatment adherence shorten inpatient treatment alleviate PS faster and will facilitate implementation in clinical practice
Data from OCoPS-P BASEC 2018-02164 clinicaltrialsgov NCT03921450 double-blind RCT indicate that 15 sessions of inhibitory rTMS over three weeks on the supplementary motor area SMA alleviate PS
However three weeks of one daily rTMS session is rather inconvenient for patients and medical professionals Therefore this study will aim to optimize the treatment protocol with regard to efficiency and efficacy by using an accelerated rTMS protocol with continuous theta-burst stimulation cTBS Inhibitory cTBS will be applied 3 times per day over 5 days which will increase the session frequency and shorten sessions and treatment duration
Reducing the duration of the treatment phase might increase treatment adherence shorten inpatient treatment alleviate PS faster and will facilitate implementation in clinical practice
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?:
True
Is an FDA AA801 Violation?:
None