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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLPFC facilitatory | Active Comparator | repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing |
|
| preSMA/SMA inhibitory | Experimental | repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices |
|
| preSMA/SMA facilitatory | Experimental | intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices |
|
| sham TMS | Sham Comparator | sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLPFC facilitatory | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 3 |
| Change in Activity Level From Baseline to Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Walther, MD | University of Bern, University Hospital of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Psychiatry, University of Bern | Bern | 3008 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | DLPFC Facilitatory | repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing DLPFC facilitatory: 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 |
| FG001 | preSMA/SMA Inhibitory | repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices SMA inhibitory: 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 |
| FG002 | preSMA/SMA Facilitatory | intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices SMA facilitatory: 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 |
| FG003 | Sham TMS | sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) sham TMS: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
one subject randomized withdrew consent before the baseline assessments
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| ID | Title | Description |
|---|---|---|
| BG000 | DLPFC Facilitatory | repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing DLPFC facilitatory: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | responders | week 3 |
|
Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DLPFC Facilitatory | repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing DLPFC facilitatory: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deterioration of psychiatric disorder | Psychiatric disorders | Systematic Assessment | one patient experienced a deterioration of the underlying psychiatric disorder (major depression), which required short term hospitalization. The intervention was stopped. The problem resolved and the patient was discharged from the hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild nausea | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Sebastian Walther | University of Bern, University Hospital of Psychiatry, Bern | +41 632 8979 | sebastian.walther@upd.unibe.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2015 | May 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011596 | Psychomotor Disorders |
| D012559 | Schizophrenia |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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double-blind
|
| SMA inhibitory | Other | 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 |
|
|
| SMA facilitatory | Other | 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 |
|
|
| sham TMS | Other | 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 |
|
actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h |
| 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 | 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 | 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 | 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 | 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 | 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 | week 3 |
| Change in CAINS Total Score From Baseline to Week 3 | the clinical assessment interview for negative symptoms, assessment blind to intervention | 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 | week 3 |
| BG001 | preSMA/SMA Inhibitory | repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices SMA inhibitory: 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 |
| BG002 | preSMA/SMA Facilitatory | intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices SMA facilitatory: 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 |
| BG003 | Sham TMS | sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) sham TMS: 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Number | participants |
|
| OG002 | preSMA/SMA Facilitatory | intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices SMA facilitatory: 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 |
| OG003 | Sham TMS | sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) sham TMS: 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 |
|
|
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| Secondary | Change in CAINS Total Score From Baseline to Week 3 | the clinical assessment interview for negative symptoms, assessment blind to intervention | Not Posted | week 3 | Participants |
| Secondary | 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 | Not Posted | week 3 | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | preSMA/SMA Inhibitory | repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices SMA inhibitory: 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 | 0 | 11 | 0 | 11 | 1 | 11 |
| EG002 | preSMA/SMA Facilitatory | intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices SMA facilitatory: 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 | 0 | 11 | 1 | 11 | 0 | 11 |
| EG003 | Sham TMS | sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) sham TMS: 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 | 0 | 10 | 0 | 10 | 1 | 10 |
|
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| altered visual perception | Nervous system disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|