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Completed

NCT Number: NCT03275766

Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in 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.

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Key information

Conditions

Psychomotor Retardation Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Psychomotor Slowing Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia and Related Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Psychiatry, University of Bern

Bern, 3008, Switzerland

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria
  • right handedness
  • normal or corrected-to-normal vision and hearing

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

Treatment and study plan

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

Other names: rTMS facilitatory DLPFC

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

Other names: rTMS inhibitory SMA

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

Other names: iTBS facilitatory SMA

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3

    Time frame: 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

  2. Change in Activity Level From Baseline to Week 3

    Time frame: week 3

    actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h

  3. Change in Catatonia Severity From Baseline to Week 3

    Time frame: week 3

    observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention

  4. Change in Fingertapping Score From Baseline to Week 3

    Time frame: week 3

    Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment

  5. Change in Coin Rotation From Baseline to Week 3

    Time frame: week 3

    test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation

  6. Change in Hand Gesture Performance From Baseline to Week 3

    Time frame: week 3

    videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating

  7. Change in SANS Total Score From Baseline to Week 3

    Time frame: week 3

    scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention

  8. Change From HAMD Total Score From Baseline to Week 3

    Time frame: week 3

    Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention

  9. Change in CAINS Total Score From Baseline to Week 3

    Time frame: week 3

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

  10. Change in PANSS Total and Subscores From Baseline to Week 3

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 8, 2017
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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