Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders (NCT NCT03275766)
NCT ID: NCT03275766
Last Updated: 2021-05-12
Results Overview
Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
week 3
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
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
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
|
preSMA/SMA Inhibitory
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices
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
|
preSMA/SMA Facilitatory
intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices
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
sham rTMS with a placebo coil over occipital cortex
should have no effect at all (no transcranial magnetic stimulation, only sound)
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
11
|
10
|
|
Overall Study
Received Intervention
|
9
|
11
|
10
|
9
|
|
Overall Study
COMPLETED
|
7
|
5
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DLPFC Facilitatory
n=12 Participants
repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC
usually effective in depression treatment, probably no specific effect on psychomotor slowing
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
|
preSMA/SMA Inhibitory
n=11 Participants
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices
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
|
preSMA/SMA Facilitatory
n=11 Participants
intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices
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
n=10 Participants
sham rTMS with a placebo coil over occipital cortex
should have no effect at all (no transcranial magnetic stimulation, only sound)
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
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 15.2 • n=12 Participants
|
38.0 years
STANDARD_DEVIATION 15.6 • n=11 Participants
|
34.2 years
STANDARD_DEVIATION 14.0 • n=11 Participants
|
41.2 years
STANDARD_DEVIATION 15.3 • n=10 Participants
|
39.5 years
STANDARD_DEVIATION 15.0 • n=44 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
8 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
7 Participants
n=10 Participants
|
31 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
44 participants
n=44 Participants
|
|
Diagnosis
major depression
|
5 participants
n=12 Participants
|
5 participants
n=11 Participants
|
5 participants
n=11 Participants
|
4 participants
n=10 Participants
|
19 participants
n=44 Participants
|
|
Diagnosis
schizophrenia
|
7 participants
n=12 Participants
|
6 participants
n=11 Participants
|
6 participants
n=11 Participants
|
6 participants
n=10 Participants
|
25 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: week 3Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
Outcome measures
| Measure |
DLPFC Facilitatory
n=12 Participants
repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC
usually effective in depression treatment, probably no specific effect on psychomotor slowing
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
|
preSMA/SMA Inhibitory
n=11 Participants
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices
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
|
preSMA/SMA Facilitatory
n=11 Participants
intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices
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
n=10 Participants
sham rTMS with a placebo coil over occipital cortex
should have no effect at all (no transcranial magnetic stimulation, only sound)
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
|
|---|---|---|---|---|
|
Number of Responders at Week 3
|
4 responders
|
9 responders
|
0 responders
|
3 responders
|
SECONDARY outcome
Timeframe: week 3observer based rating scale of the severity of psychomotor slowing, assessment blind to intervention Scores may range from 0 - 60, higher scores indicate worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3actigraphically (wrist of the non-dominant arm) assessed motor activity during the wake periods of one day, given in counts/h
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale, assessment blind to intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3Fingertapping test with the dominant and nondominant index finger for 10 sec, video-taped and blind assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3test of manual dexterity in both hands, rotation of a specified coin for 10 seconds, video-taped and blinded evaluation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3videotaped performance of hand gestures according to the Test of Upper Limb Apraxia (TULIA), blind evaluation and rating
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3scale for the assessment of negative symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3Hamilton Rating Scale for Depression, 21-item version, applies to depression patients, assessment blind to intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3the clinical assessment interview for negative symptoms, assessment blind to intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 3the positive and negative syndrome scale, interview to assess severity of schizophrenia symptoms, applies to schizophrenia spectrum disorder patients, assessment blind to intervention
Outcome measures
Outcome data not reported
Adverse Events
DLPFC Facilitatory
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
preSMA/SMA Inhibitory
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
preSMA/SMA Facilitatory
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DLPFC Facilitatory
n=12 participants at risk
repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC
usually effective in depression treatment, probably no specific effect on psychomotor slowing
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
|
preSMA/SMA Inhibitory
n=11 participants at risk
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices
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
|
preSMA/SMA Facilitatory
n=11 participants at risk
intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices
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
n=10 participants at risk
sham rTMS with a placebo coil over occipital cortex
should have no effect at all (no transcranial magnetic stimulation, only sound)
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
|
|---|---|---|---|---|
|
Psychiatric disorders
Deterioration of psychiatric disorder
|
0.00%
0/12 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
9.1%
1/11 • Number of events 1 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/10 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
Other adverse events
| Measure |
DLPFC Facilitatory
n=12 participants at risk
repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC
usually effective in depression treatment, probably no specific effect on psychomotor slowing
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
|
preSMA/SMA Inhibitory
n=11 participants at risk
repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA
should inhibit overactive premotor cortices
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
|
preSMA/SMA Facilitatory
n=11 participants at risk
intermittend theta burst stimulation (iTBS) over preSMA/SMA
should facilitate neural activity within premotor cortices
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
n=10 participants at risk
sham rTMS with a placebo coil over occipital cortex
should have no effect at all (no transcranial magnetic stimulation, only sound)
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
|
|---|---|---|---|---|
|
Nervous system disorders
mild nausea
|
0.00%
0/12 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
9.1%
1/11 • Number of events 1 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/10 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/12 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
10.0%
1/10 • Number of events 1 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
|
Nervous system disorders
altered visual perception
|
8.3%
1/12 • Number of events 1 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/11 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
0.00%
0/10 • Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
inquiry with open questions
|
Additional Information
Prof. Sebastian Walther
University of Bern, University Hospital of Psychiatry, Bern
Phone: +41 632 8979
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place