- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275766
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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:
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3008
- University Hospital of Psychiatry, University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
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
Other Names:
|
Experimental: preSMA/SMA inhibitory
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices |
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
Other Names:
|
Experimental: preSMA/SMA facilitatory
intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices |
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
Other Names:
|
Sham Comparator: sham TMS
sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Responders at Week 3
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3
Time Frame: 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
|
Change in Activity Level From Baseline to Week 3
Time Frame: 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
|
Change in Catatonia Severity From Baseline to Week 3
Time Frame: week 3
|
observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention
|
week 3
|
Change in Fingertapping Score From Baseline to Week 3
Time Frame: week 3
|
Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment
|
week 3
|
Change in Coin Rotation From Baseline to Week 3
Time Frame: week 3
|
test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation
|
week 3
|
Change in Hand Gesture Performance From Baseline to Week 3
Time Frame: week 3
|
videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating
|
week 3
|
Change in SANS Total Score From Baseline to Week 3
Time Frame: week 3
|
scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
|
week 3
|
Change From HAMD Total Score From Baseline to Week 3
Time Frame: week 3
|
Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention
|
week 3
|
Change in CAINS Total Score From Baseline to Week 3
Time Frame: week 3
|
the clinical assessment interview for negative symptoms, assessment blind to intervention
|
week 3
|
Change in PANSS Total and Subscores From Baseline to Week 3
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNCTP610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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