An interventional study of 1 Hz rTMS and iTBS in Schizophrenia and Related Disorders, Schizophrenia and Schizoaffective Disorder, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 103 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
1 Hz stimulation of 17 mins over the supplementary motor area (SMA), 1000 pulses at 110% resting motor threshold intensity total of 15 sessions in 3 weeks
Device: 1 Hz rTMS
Intermittent theta burst stimulation of 50 Hz over the supplementary motor area (SMA) with 600 pulses in 2 sec trains every 10 seconds for 190 seconds total. Two iTBS stimulations will be administered with 15 mins pause in between. total of 15 sessions in 3 weeks
Device: iTBS
1 Hz stimulation of 17 mins over the supplementary motor area (SMA) without any magnetic emission using a placebo-coil that looks identical and makes identical sounds as the real TMS coil total of 15 sessions in 3 weeks
Drug: Placebo
This group will receive no intervention for 3 weeks. Afterwards they will receive the inhibitory rTMS protocol as in the first arm
1 Hz stimulation at 110% of resting motor threshold over supplementary motor area
50 Hz theta burst stimulation at 80% of resting motor threshold over supplementary motor area
1 Hz stimulation with the placebo TMS coil without any magnetic emission
Proportion of responders at week 3
Proportion of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale (SRRS)
Time frame: Week 3
Change in Salpetriere Retardation Rating Scale (SSRS) from baseline
Change in the Salpetriere Retardation Rating Scale (SRRS) from baseline; the total score of 15 items is used, ranging 0-60 with higher scores indicating worse outcome
Time frame: Week 3, week 6, week 24
Change in catatonia severity from baseline to week 3
Observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale (BFCRS), assessment blind to intervention, total score of the BFCRS is used ranging 0-69 , with higher scores indicating poorer outcome
Time frame: Week 3, week 6, week 24
Change in negative symptoms from baseline
Change in the Brief Negative Symptom Scale (BNSS) from baseline, total score is used, ranging from 0-78 with higher values indicating poorer outcome, i.e. more negative symptom severity
Time frame: Week 3, week 6, week 24
Change in psychosis severity from baseline
Change in the Positive And Negative Symptom Scale (PANSS) from baseline, PANSS total score assesses the severity of positive, negative and general symptoms, ranging from 30-210 with higher scores indicating increased symptom severity, i.e. poorer outcome
Time frame: Week 3, week 6, week 24
Change in physical activity self report from baseline
Change in the International Physical Activity Questionnaire (IPAQ), the total score is used ranging from 0-70000 metabolic equivalent (MET)
Time frame: Week 3, week 6, week 24
Change in objectively measured physical activity from baseline
Change in the activity levels using wrist actigraphy
Time frame: Week 3, week 6, week 24
Change in dexterity from baseline
Change in the coin rotation task from baseline
Time frame: Week 3, week 6, week 24
Change in cortical excitability of the motor cortex from baseline
Change in Short Interval Cortical Inhibition (SICI) from baseline
Time frame: Week 3, week 6, week 24
Change in social and community functioning
Change in Social and Occupational Functional Assesment Scale (SOFAS) from baseline, the score ranges from 0-100 with higher scores indicating better functioning, i.e. better outcome
Time frame: Week 3, week 6, week 24
Change in functional capacity
Change in the Score of the brief version of the University of California, San Diego, Performance-Based Skills Assessment (UPSA-brief) assessment from baseline, higher scores indicating better function, the total score is used ranging 0-100
Time frame: Week 3, week 6, week 24
Change in functional connectivity
Change in the resting state functional connectivity within the cerebral motor system based on functional magnetic resonance imaging scans from baseline
Time frame: Week 3
Change in resting state cerebral perfusion
Change in the resting state cerebral perfusion within the cerebral motor system based on functional magnetic resonance imaging scans from baseline
Time frame: Week 3
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University of Bern