Psychomotor RetardationNCT03275766
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
A study testing DLPFC facilitatory, SMA inhibitory and SMA facilitatory in people with Psychomotor Retardation and Psychomotor Slowing, run by University of Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychomotor Retardation, Psychomotor Slowing, Schizophrenia and Related Disorders
- What is being tested?
- DLPFC facilitatory, SMA inhibitory and SMA facilitatory
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2016to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria
- right handedness
- normal or corrected-to-normal vision and hearing
Who cannot join
- epilepsy
- history of severe head trauma
- current abuse of drugs or alcohol; past addiction to drugs or alcohol
- pregnancy
- incompatibility to cerebral MRI
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry, University of Bern
Bern, 3008
About this study
Official title: Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders
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.
Read the detailed description
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:
- Conditions
- Psychomotor Retardation, Psychomotor Slowing, Schizophrenia and Related Disorders, Major Depressive Disorder
- Being tested
- DLPFC facilitatory, SMA inhibitory, SMA facilitatory, sham TMS
- Medical subject headings
- Psychomotor Disorders, Schizophrenia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLPFC facilitatoryOther
Also called rTMS facilitatory DLPFC
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
SMA inhibitoryOther
Also called rTMS inhibitory SMA
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 facilitatoryOther
Also called iTBS facilitatory SMA
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 TMSOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: DLPFC facilitatory |
| preSMA/SMA inhibitory | Experimental | repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices Receives: Other: SMA inhibitory |
| preSMA/SMA facilitatory | Experimental | intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices Receives: Other: SMA facilitatory |
| 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) Receives: Other: sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 3
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 3
Change in CAINS Total Score From Baseline to Week 3
the clinical assessment interview for negative symptoms, assessment blind to intervention
Measured: 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
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Jun 2016
- Primary completion1 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor RetardationStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Walther, University of Bern
- Investigators
- Sebastian Walther, MD, Principal investigator, University of Bern, University Hospital of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275766
- Sponsor's protocol ID
- SNCTP610
- Status last verified
- May 2021
- First submitted
- 22 Aug 2017
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walther S, Alexaki D, Schoretsanitis G, Weiss F, Vladimirova I, Stegmayer K, Strik W, Schappi L. Inhibitory Repetitive Transcranial Magnetic Stimulation to Treat Psychomotor Slowing: A Transdiagnostic, Mechanism-Based Randomized Double-Blind Controlled Trial. Schizophr Bull Open. 2020 Apr 22;1(1):sgaa020. doi: 10.1093/schizbullopen/sgaa020. eCollection 2020 Jan.
PubMed 42936210
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT03275766
- Acronym / sponsor ID
- SNCTP610
- Conditions
- Psychomotor Retardation, Psychomotor Slowing, Schizophrenia and Related Disorders, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Posted 12 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DLPFC facilitatory | Active comparator | Other: DLPFC facilitatoryrepetitive 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 | Other: SMA inhibitoryrepetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices |
| preSMA/SMA facilitatory | Experimental | Other: SMA facilitatoryintermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices |
| sham TMS | Sham comparator | Other: sham TMSsham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria
- right handedness
- normal or corrected-to-normal vision and hearing
Key exclusion criteria (5 listed)
- epilepsy
- history of severe head trauma
- current abuse of drugs or alcohol; past addiction to drugs or alcohol
- pregnancy
- incompatibility to cerebral MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLPFC facilitatoryAlso: rTMS facilitatory DLPFC15 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 | Other | DLPFC facilitatory |
| SMA inhibitoryAlso: rTMS inhibitory SMA1 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 | Other | preSMA/SMA inhibitory |
| SMA facilitatoryAlso: iTBS facilitatory SMAThree 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 | Other | preSMA/SMA facilitatory |
| sham TMSDetermination 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 | Other | sham TMS |
Primary outcome
Number of Responders at Week 3
Time frame: week 3
Number of participants with >30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
10 secondary outcomes
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3
Time frame: week 3
Change in Activity Level From Baseline to Week 3
Time frame: week 3
Change in Catatonia Severity From Baseline to Week 3
Time frame: week 3
Change in Fingertapping Score From Baseline to Week 3
Time frame: week 3
Change in Coin Rotation From Baseline to Week 3
Time frame: week 3
Change in Hand Gesture Performance From Baseline to Week 3
Time frame: week 3
Change in SANS Total Score From Baseline to Week 3
Time frame: week 3
Change From HAMD Total Score From Baseline to Week 3
Time frame: week 3
Change in CAINS Total Score From Baseline to Week 3
Time frame: week 3
Change in PANSS Total and Subscores From Baseline to Week 3
Time frame: week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42936210Walther S, Alexaki D, Schoretsanitis G, Weiss F, Vladimirova I, Stegmayer K, Strik W, Schappi L. Inhibitory Repetitive Transcranial Magnetic Stimulation to Treat Psychomotor Slowing: A Transdiagnostic, Mechanism-Based Randomized Double-Blind Controlled Trial. Schizophr Bull Open. 2020 Apr 22;1(1):sgaa020. doi: 10.1093/schizbullopen/sgaa020. eCollection 2020 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Walther, MD principal investigator
University of Bern, University Hospital of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLPFC facilitatory, SMA inhibitory and SMA facilitatory in people with Psychomotor Retardation and Psychomotor Slowing, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responders at Week 3 (time frame: week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03275766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.