Overcoming Psychomotor Slowing in Psychosis (OCoPS-P) (OCoPS-P)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    88
  • sponsor
    University of Bern
Updated on 3 February 2022
psychosis
schizophrenia
Accepts healthy volunteers

Summary

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.

Description

As psychomotor slowing is a major problem in schizophrenia, contributing to poor functional outcome, and as no current treatment is effectively targeting psychomotor slowing, this study seeks to test noninvasive brain stimulation to overcome psychomotor slowing. Previous studies documented an aberrant increase of neural activity within the supplementary motor area (SMA) in patients with schizophrenia who had psychomotor slowing. Furthermore, a pilot study in major depression and schizophrenia indicated that inhibitory 1 Hz repetitive transcranial magnetic stimulation (rTMS) would improve psychomotor slowing in 82% of the participants. While this is encouraging, further evidence is needed to 1) replicate the clinical effect of 1 Hz rTMS on the SMA in schizophrenia, 2) to test against sham stimulation, facilitatory stimulation and no intervention, and 3) to test the effects of rTMS on the neural circuitry. Therefore, OCoPS includes more patients, more treatment arms, and more outcome variables than the first pilot trial.

Here we will enroll 88 patients with schizophrenia spectrum disorders and severe psychomotor slowing according to a standard rating scale. Subjects will be randomized to four arms, three of which are double blinded.

three weeks of daily rTMS over the SMA will be delivered. The first group receives inhibitory 1 Hz rTMS, the second group receives facilitatory intermittent theta burst stimulation (iTBS), and the third group receives sham stimulation with a placebo-coil. The fourth group will have no rTMS during the first three weeks, but will repeat the baseline measures after three weeks and then enter a treatment with 1Hz rTMS for three weeks. Outcome measures include the Salpetriere Retardation Rating Scale, observer ratings of motor behavior as well as measures of functioning. After the interventions, follow-up visits are planned at week 6 and week 24.

Finally, at baseline and after the rTMS course, patients will undergo MRI scanning for structural and functional alterations of the cerebral motor system.

Details
Condition Schizophrenia and Related Disorders, Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder
Treatment Placebo, 1 Hz rTMS, iTBS
Clinical Study IdentifierNCT03921450
SponsorUniversity of Bern
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

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
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