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CompletedNCT03275766Updated May 12, 2021Results posted

Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders

An interventional study of DLPFC facilitatory and SMA inhibitory in Psychomotor Retardation, Psychomotor Slowing and Schizophrenia and Related Disorders, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by University of Bern · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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:

02

Conditions studied

  • Psychomotor Retardation
  • Psychomotor Slowing
  • Schizophrenia and Related Disorders
  • Major Depressive Disorder
03

In context

Psychomotor Disorders

51 studies on the registry are indexed under Psychomotor Disorders; 8 are open to participants now.

This study's enrollment of 45 is below the median of 59 across 36 interventional studies indexed under Psychomotor Disorders.

Browse Psychomotor Disorders studies →

Lead sponsor

University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.

Browse University of Bern studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • suffering from major depressive disorder or schizophrenia spectrum disorder according to criteria
  • right handedness
  • normal or corrected-to-normal vision and hearing

Exclusion criteria

Exclusion Criteria:

  • epilepsy
  • history of severe head trauma
  • current abuse of drugs or alcohol; past addiction to drugs or alcohol
  • pregnancy
  • incompatibility to cerebral MRI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    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

    Other: DLPFC facilitatory

  • Experimental
    preSMA/SMA inhibitory

    repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices

    Other: SMA inhibitory

  • Experimental
    preSMA/SMA facilitatory

    intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices

    Other: SMA facilitatory

  • Sham comparator
    sham TMS

    sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound)

    Other: sham TMS

Interventions

  • OtherDLPFC 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

    Also known as: rTMS facilitatory DLPFC

  • OtherSMA 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

    Also known as: rTMS inhibitory SMA

  • OtherSMA 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

    Also known as: iTBS facilitatory SMA

  • Othersham 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

07

Results

Posted May 12, 2021

Participant flow

Participant flow — Overall Study
MilestoneDLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMS
Started12121110
Received intervention911109
Completed7574
Not completed5746

Outcome measures

PrimaryNumber 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
Reported as:
Number · responders
Number of Responders at Week 3
respondersDLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMS
Number of Responders at Week 34903
SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange in CAINS Total Score From Baseline to Week 3

the clinical assessment interview for negative symptoms, assessment blind to intervention

Time frame:
week 3

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

Adverse events

Collected over Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DLPFC Facilitatory0/12 (0%)0/12 (0%)1/12 (8.3%)
preSMA/SMA Inhibitory0/11 (0%)0/11 (0%)1/11 (9.1%)
preSMA/SMA Facilitatory0/11 (0%)1/11 (9.1%)0/11 (0%)
Sham TMS0/10 (0%)0/10 (0%)1/10 (10%)
Most frequent serious events
Most frequent serious events
EventDLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMS
Deterioration of psychiatric disorderPsychiatric disorders0/120/111/110/10
Most frequent other events
Most frequent other events
EventDLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMS
neck painMusculoskeletal and connective tissue disorders0/120/110/111/10
mild nauseaNervous system disorders0/121/110/110/10
altered visual perceptionNervous system disorders1/120/110/110/10

Baseline characteristics

one subject randomized withdrew consent before the baseline assessments

Age, Categorical
Age, Categorical(Participants)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
<=18 years00000
Between 18 and 65 years1211111044
>=65 years00000
Age, Continuous
Age, Continuous(years)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
Mean45.3 ± 15.238.0 ± 15.634.2 ± 14.041.2 ± 15.339.5 ± 15.0
Sex: Female, Male
Sex: Female, Male(Participants)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
Female235313
Male1086731
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(participants)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
Switzerland1211111044
Diagnosis
Diagnosis(participants)DLPFC FacilitatorypreSMA/SMA InhibitorypreSMA/SMA FacilitatorySham TMSTotal
major depression555419
schizophrenia766625
08

Study locations

1 site
  • University Hospital of Psychiatry, University of Bern
    Bern, 3008, Switzerland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Jul 2019, 37 months.

Results were first posted in May 2021, 1 year 10 months after primary completion.

Of 22 interventional studies with no phase under Psychomotor Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 37. This study's 37 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Sep 8, 2017
StartActual
Jun 1, 2016
Primary completionActual
Jul 1, 2019
CompletionActual
Jul 15, 2019
Results first posted
May 12, 2021
Last update
May 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03275766
Lead sponsor
University of Bern
Responsible party
Sebastian Walther (Prof. Dr., Head of the outpatient clinic, University Hospital of Psychiatry, University of Bern) — Principal investigator
First posted
Sep 8, 2017
Start date
Jun 1, 2016
Primary completion
Jul 1, 2019
Completion
Jul 15, 2019
Results posted
May 12, 2021
Last update
May 12, 2021

Study contacts

Sebastian Walther, MD
principal investigator · University of Bern, University Hospital of Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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