Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity B… (NCT04853485) | Clinical Trial Compass
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Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes
China300 participantsStarted 2020-08-01
Plain-language summary
The present study plans to explore different cortical targets of repetitive transcranial magnetic stimulation (rTMS) for populations at the early phase of psychosis, including those at clinical high risk of psychosis and in the first episode of psychosis. The clinical augmentation efficacy will be associated with the brain functional connectivity of these populations.
Who can participate
Age range14 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For subjects at clinical high-risk for psychosis
Inclusion Criteria:
* Meeting the syndrome of clinical high risk of psychosis, identified by a face-to-face interview using the Chinese version of Structured Interview for Prodromal Syndromes / Scale of Prodromal Symptoms (SIPS/SOPS);
* Given the written consent for participation.
* Age between 14-45 years old;
* IQ\>69;
* PANSS total scores \>= 55 or BVMT-R score \<= 26;
Exclusion Criteria:
* any contraindication to TMS treatment or magnetic resonance imaging (MRI)
* substance or alcohol abuse within recent three months
* any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy ) or any other physical disease which may lead to psychotic symptoms.
For subjects with first-episode schizophrenia
Inclusion Criteria:
* Meeting the DSM-V diagnostic criteria for schizophrenia spectrum disorders;
* Given the written consent for participation.
* Age between 14-45 years old;
* IQ\>69;
* during the first episode without a full remission;
* PANSS total scores \>= 55 or BVMT-R score \<= 26;
* within receiving rTMS, patients can receive second-generation antipsychotics except clozapine with stable dosages
Exclusion Criteria:
* any contraindication to TMS treatment or magnetic resonance imaging (MRI)
* substance or alcohol abuse within recent three months
* any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, e…
What they're measuring
1
Response rate (the number of non-responders) for subgroup 1 and subgroup 3
Timeframe: Within 24 hours after the rTMS intervention
2
Improvement on cognition for subgroup 2
Timeframe: Within 24 hours after the rTMS intervention
Trial details
NCT IDNCT04853485
SponsorShanghai Jiao Tong University School of Medicine