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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275766
• Other study ID #: SNCTP610
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: July 15, 2019

Study information

• Verified date: May 2021
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 15, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Problem Behavior
• Psychomotor Retardation
• Psychomotor Slowing
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Other:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital of Psychiatry, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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