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

NCT03275766 | Completed Results

• 1 other identifier: SNCTP610
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  week 3

Secondary Outcomes (10)

• 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

Study Arms (4)

DLPFC facilitatory

ACTIVE COMPARATOR

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

preSMA/SMA inhibitory

EXPERIMENTAL

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

Other: SMA inhibitory

preSMA/SMA facilitatory

EXPERIMENTAL

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

Other: SMA facilitatory

sham TMS

SHAM COMPARATOR

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

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

Also known as: rTMS facilitatory DLPFC

DLPFC facilitatory

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

Also known as: rTMS inhibitory SMA

preSMA/SMA inhibitory

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

Also known as: iTBS facilitatory SMA

preSMA/SMA facilitatory

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

sham TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• epilepsy
• history of severe head trauma
• current abuse of drugs or alcohol; past addiction to drugs or alcohol
• pregnancy
• incompatibility to cerebral MRI

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry, University of Bern

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Psychomotor Disorders; Schizophrenia; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Results Point of Contact

• Title: Prof. Sebastian Walther
• Organization: University of Bern, University Hospital of Psychiatry, Bern

sebastian.walther@upd.unibe.ch

+41 632 8979

Study Officials

• Sebastian Walther, MD

  University of Bern, University Hospital of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr., Head of the outpatient clinic, University Hospital of Psychiatry

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 8, 2017
• Study Start: June 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 15, 2019
• Last Updated: May 12, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)