Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.
Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of rTMS in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major depression. Eligible participants will be randomized to one of four arms:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
45
15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli
1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli
Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli
Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session
University Hospital of Psychiatry, University of Bern
Bern, Switzerland
Number of Responders at Week 3
Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
Time frame: week 3
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3
observer based rating scale of the severity of psychomotor slowing, assessment blind to intervention Scores may range from 0 - 60, higher scores indicate worse outcome
Time frame: week 3
Change in Activity Level From Baseline to Week 3
actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h
Time frame: week 3
Change in Catatonia Severity From Baseline to Week 3
observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention
Time frame: week 3
Change in Fingertapping Score From Baseline to Week 3
Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment
Time frame: week 3
Change in Coin Rotation From Baseline to Week 3
test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation
Time frame: week 3
Change in Hand Gesture Performance From Baseline to Week 3
videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating
Time frame: week 3
Change in SANS Total Score From Baseline to Week 3
scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Time frame: week 3
Change From HAMD Total Score From Baseline to Week 3
Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention
Time frame: week 3
Change in CAINS Total Score From Baseline to Week 3
the clinical assessment interview for negative symptoms, assessment blind to intervention
Time frame: week 3
Change in PANSS Total and Subscores From Baseline to Week 3
the positive and negative syndrome scale, interview to assess severity of schizophrenia symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Time frame: week 3
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