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

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

Sponsors

Lead Sponsor: University of Bern

Source 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:

Overall Status Completed
Start Date 2016-06-01
Completion Date 2019-07-15
Primary Completion Date 2019-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Responders at Week 3 week 3
Secondary Outcome
Measure Time Frame
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3 week 3
Change in Activity Level From Baseline to Week 3 week 3
Change in Catatonia Severity From Baseline to Week 3 week 3
Change in Fingertapping Score From Baseline to Week 3 week 3
Change in Coin Rotation From Baseline to Week 3 week 3
Change in Hand Gesture Performance From Baseline to Week 3 week 3
Change in SANS Total Score From Baseline to Week 3 week 3
Change From HAMD Total Score From Baseline to Week 3 week 3
Change in CAINS Total Score From Baseline to Week 3 week 3
Change in PANSS Total and Subscores From Baseline to Week 3 week 3
Enrollment 45
Condition
Intervention

Intervention Type: Other

Intervention Name: DLPFC facilitatory

Description: 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

Arm Group Label: DLPFC facilitatory

Other Name: rTMS facilitatory DLPFC

Intervention Type: Other

Intervention Name: SMA inhibitory

Description: 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

Arm Group Label: preSMA/SMA inhibitory

Other Name: rTMS inhibitory SMA

Intervention Type: Other

Intervention Name: SMA facilitatory

Description: 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

Arm Group Label: preSMA/SMA facilitatory

Other Name: iTBS facilitatory SMA

Intervention Type: Other

Intervention Name: sham TMS

Description: 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

Arm Group Label: sham TMS

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Sebastian Walther, MD Principal Investigator University of Bern, University Hospital of Psychiatry
Location
Facility: University Hospital of Psychiatry, University of Bern
Location Countries

Switzerland

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Bern

Investigator Full Name: Sebastian Walther

Investigator Title: Prof. Dr., Head of the outpatient clinic, University Hospital of Psychiatry

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: DLPFC facilitatory

Type: Active Comparator

Description: repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing

Label: preSMA/SMA inhibitory

Type: Experimental

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

Label: preSMA/SMA facilitatory

Type: Experimental

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

Label: sham TMS

Type: Sham Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Outcomes Assessor)

Masking Description: double-blind

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