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

NCT ID: NCT03275766

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-07-15

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:

Conditions

Psychomotor Retardation; Psychomotor Slowing; Schizophrenia and Related Disorders; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

DLPFC facilitatory

Intervention Type: 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

preSMA/SMA inhibitory

repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA

should inhibit overactive premotor cortices

Group Type: EXPERIMENTAL

SMA inhibitory

Intervention Type: 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

preSMA/SMA facilitatory

intermittend theta burst stimulation (iTBS) over preSMA/SMA

should facilitate neural activity within premotor cortices

Group Type: EXPERIMENTAL

SMA facilitatory

Intervention Type: 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

sham TMS

sham rTMS with a placebo coil over occipital cortex

should have no effect at all (no transcranial magnetic stimulation, only sound)

Group Type: SHAM_COMPARATOR

sham TMS

Intervention Type: 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

Interventions

DLPFC 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

Intervention Type: OTHER

SMA 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

Intervention Type: OTHER

SMA 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

Intervention Type: OTHER

sham 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

Intervention Type: OTHER

Other Intervention Names

rTMS facilitatory DLPFC; rTMS inhibitory SMA; iTBS facilitatory SMA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Walther

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Walther, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern, University Hospital of Psychiatry

Locations

University Hospital of Psychiatry, University of Bern

Bern, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SNCTP610

Identifier Type: -

Identifier Source: org_study_id