Overcoming Psychomotor Slowing in Psychosis (OCoPS-P): a 3-week, Randomized, Double-blind, Placebo-controlled Trial of add-on Repetitive Transcranial Magnetic Stimulation for Psychomotor Slowing in Psychosis

2018-02164

Psychomotor slowing is a major problem in psychosis. Aberrant function of the cerebral motor system is linked to psychomotor slowing in patients, particularly resting state hyperactivity in premotor cortices. A previous clinical trial indicated that inhibitory stimulation of the premotor cortex would reduce psychomotor slowing. The current study is further exploring this effect in a randomized, placebo-controlled, double-blind design with three arms of transcranial magnetic stimulation and measures of brain imaging and physiology prior to and after the intervention.

2019-03-25

2022-11-01

2023-02-10

Completed

103

Inclusion Criteria: * Right-handed subjects * Ability and willingness to participate in the study * Ability to provide written informed consent * Informed Consent as documented by signature * Schizophrenia spectrum disorder according to diagnostic and statistical manual version 5 (DSM-5) criteria with current psychomotor slowing according to the Salpetriere Retardation Rating Scale (SRRS), score \>= 15 Exclusion Criteria: * Substance abuse or dependence other than nicotine * Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness. * Epilepsy or other convulsions * History of any hearing problems or ringing in the ears * Standard exclusion criteria for MRI scanning and TMS; e.g. metal implants, claustrophobia * Patients only: any TMS treatment in the past 3 months * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons * Controls only: history of any psychiatric disorder or first-degree relatives with schizophrenia spectrum disorders.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 week intervention with 15 sessions of add-on rTMS in 4 parallel arms, randomized, double-blind, placebo-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants will not know the stimulation protocol, neither will the outcome assessor or the mental health care provider know the protocol applied', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 103, 'type': 'ACTUAL'}}

2023-02-14