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

Not Applicable

Completed

• Conditions: Psychomotor Slowing; Schizophrenia and Related Disorders; Psychomotor Retardation; Major Depressive Disorder
• Interventions: Other: sham TMS; Other: SMA inhibitory; Other: SMA facilitatory; Other: DLPFC facilitatory

• Registration Number: NCT03275766
• Lead Sponsor: University of Bern

Brief 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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-08
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-15
• Results First Submitted: 2020-05-26
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham TMS	sham TMS	sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound)
preSMA/SMA inhibitory	SMA inhibitory	repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices
preSMA/SMA facilitatory	SMA facilitatory	intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices
DLPFC facilitatory	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

Primary Outcome Measures

Name	Time	Method
Number of Responders at Week 3	week 3	Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied

Secondary Outcome Measures

Name	Time	Method
Change in Hand Gesture Performance From Baseline to Week 3	week 3	videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3	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
Change in Activity Level From Baseline to Week 3	week 3	actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h
Change in SANS Total Score From Baseline to Week 3	week 3	scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Change in CAINS Total Score From Baseline to Week 3	week 3	the clinical assessment interview for negative symptoms, assessment blind to intervention
Change in PANSS Total and Subscores From Baseline to Week 3	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
Change in Coin Rotation From Baseline to Week 3	week 3	test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation
Change in Catatonia Severity From Baseline to Week 3	week 3	observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention
Change in Fingertapping Score From Baseline to Week 3	week 3	Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment
Change From HAMD Total Score From Baseline to Week 3	week 3	Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention

Trial Locations

Locations (1)

University Hospital of Psychiatry, University of Bern; 🇨🇭 Bern, Switzerland