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

Primary Purpose

Psychomotor Retardation, Psychomotor Slowing, Schizophrenia and Related Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
DLPFC facilitatory
SMA inhibitory
SMA facilitatory
sham TMS
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychomotor Retardation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Psychiatry, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Sham Comparator

Arm Label

DLPFC facilitatory

preSMA/SMA inhibitory

preSMA/SMA facilitatory

sham TMS

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
Change in CAINS Total Score From Baseline to Week 3
the clinical assessment interview for negative symptoms, assessment blind to intervention
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

Full Information

First Posted
August 22, 2017
Last Updated
May 11, 2021
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03275766
Brief Title
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
Official Title
Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Retardation, Psychomotor Slowing, Schizophrenia and Related Disorders, Major Depressive Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLPFC facilitatory
Arm Type
Active Comparator
Arm Description
repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing
Arm Title
preSMA/SMA inhibitory
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices
Arm Title
preSMA/SMA facilitatory
Arm Type
Experimental
Arm Description
intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices
Arm Title
sham TMS
Arm Type
Sham Comparator
Arm Description
sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound)
Intervention Type
Other
Intervention Name(s)
DLPFC facilitatory
Other Intervention Name(s)
rTMS facilitatory DLPFC
Intervention 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
Intervention Type
Other
Intervention Name(s)
SMA inhibitory
Other Intervention Name(s)
rTMS inhibitory SMA
Intervention 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
Intervention Type
Other
Intervention Name(s)
SMA facilitatory
Other Intervention Name(s)
iTBS facilitatory SMA
Intervention 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
Intervention Type
Other
Intervention Name(s)
sham TMS
Intervention 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
Primary Outcome Measure Information:
Title
Number of Responders at Week 3
Description
Number of participants with >30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
Time Frame
week 3
Secondary Outcome Measure Information:
Title
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3
Description
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
Time Frame
week 3
Title
Change in Activity Level From Baseline to Week 3
Description
actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h
Time Frame
week 3
Title
Change in Catatonia Severity From Baseline to Week 3
Description
observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention
Time Frame
week 3
Title
Change in Fingertapping Score From Baseline to Week 3
Description
Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment
Time Frame
week 3
Title
Change in Coin Rotation From Baseline to Week 3
Description
test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation
Time Frame
week 3
Title
Change in Hand Gesture Performance From Baseline to Week 3
Description
videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating
Time Frame
week 3
Title
Change in SANS Total Score From Baseline to Week 3
Description
scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Time Frame
week 3
Title
Change From HAMD Total Score From Baseline to Week 3
Description
Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention
Time Frame
week 3
Title
Change in CAINS Total Score From Baseline to Week 3
Description
the clinical assessment interview for negative symptoms, assessment blind to intervention
Time Frame
week 3
Title
Change in PANSS Total and Subscores From Baseline to Week 3
Description
the positive and negative syndrome scale, interview to assess severity of schizophrenia symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Time Frame
week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Walther, MD
Organizational Affiliation
University of Bern, University Hospital of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Psychiatry, University of Bern
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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