Trial Outcomes & Findings for Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia (NCT NCT01940939)
NCT ID: NCT01940939
Last Updated: 2018-10-29
Results Overview
The assessment of negative symptoms were measured with the Positive and Negative Symptom Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS).The SANS contains 30 particular items divided into 5 symptomatological domains: 1) affective flattening and/or blunting, 2) alogia, 3) avolition and/or apathy, 4) anhedonia, and 5) impaired attention. Each item is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 150. Higher scores indicate more impairment.The PANSS contains 30 particular items divided into 3 subscores: 1)positive, 2) negative, and 3) general subscore. Each item is scored on a scale from 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. The primary outcomes were the changes in the severity of negative symptoms as measured with SANS total score and PANSS negative subscore after 4 weeks of intervention.
COMPLETED
NA
70 participants
Baseline, after 4 weeks of treatment
2018-10-29
Participant Flow
Participant milestones
| Measure |
Active rTMS
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
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|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Active rTMS
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
Baseline Characteristics
Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia
Baseline characteristics by cohort
| Measure |
Active rTMS
n=35 Participants
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
n=35 Participants
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, after 4 weeks of treatmentPopulation: Ten patients dropped out due to different reasons (three patients refused to participated, three did not complianted and the other four were discharged before completion of study)
The assessment of negative symptoms were measured with the Positive and Negative Symptom Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS).The SANS contains 30 particular items divided into 5 symptomatological domains: 1) affective flattening and/or blunting, 2) alogia, 3) avolition and/or apathy, 4) anhedonia, and 5) impaired attention. Each item is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 150. Higher scores indicate more impairment.The PANSS contains 30 particular items divided into 3 subscores: 1)positive, 2) negative, and 3) general subscore. Each item is scored on a scale from 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. The primary outcomes were the changes in the severity of negative symptoms as measured with SANS total score and PANSS negative subscore after 4 weeks of intervention.
Outcome measures
| Measure |
Active rTMS
n=33 Participants
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
n=27 Participants
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
|---|---|---|
|
The Change in the Severity of Negative Symptoms
SANS（Baseline）
|
48.09 units on a scale
Interval 31.0 to 78.0
|
50.33 units on a scale
Interval 35.0 to 91.0
|
|
The Change in the Severity of Negative Symptoms
SANS（4 weeks）
|
33.91 units on a scale
Interval 23.0 to 54.0
|
41.00 units on a scale
Interval 24.0 to 70.0
|
|
The Change in the Severity of Negative Symptoms
PANSS（Baseline）
|
68.15 units on a scale
Interval 60.0 to 82.0
|
69.93 units on a scale
Interval 61.0 to 82.0
|
|
The Change in the Severity of Negative Symptoms
PANSS（4 weeks）
|
54.58 units on a scale
Interval 40.0 to 73.0
|
59.85 units on a scale
Interval 48.0 to 76.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Ten patients dropped out due to different reasons (three patients refused to participated, three did not complianted and the other four were discharged before completion of study)
MCCB in Chinese Version includes 9 tasks across 7 domains, and a composite score, including Processing Speed (Brief Assessment of Cognition in Schizophrenia Symbol Coding, Animal Fluency, Trails A), Attention (Continuous Performance Test), Working Memory (WMS-III Spatial Span), Verbal Learning (Hopkins Verbal Learning Test - Revised), Visual Learning (Brief Visuospatial Memory Test - Revised), Problem Solving (Neuropsychological Assessment Battery), and Social Cognition (Mayer-Salovey- Caruso Emotional Intelligence Test).The results are reported as T scores with a mean of 50 and an SD of 10.
Outcome measures
| Measure |
Active rTMS
n=33 Participants
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
n=27 Participants
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version
Composite score (baseline)
|
45.07 MCCB(T score)
Standard Deviation 6.48
|
43.58 MCCB(T score)
Standard Deviation 9.25
|
|
MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version
Composite score (4 weeks)
|
48.00 MCCB(T score)
Standard Deviation 7.16
|
49.04 MCCB(T score)
Standard Deviation 7.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksPopulation: patients discontinualed treatment
Alterations in gamma-band ASSR have been thought to be the most robust finding of abnormal neural oscillations in patients with schizophrenia. EEG data were acquired using a 64-electrode cap and alternating current BrainAmp amplifiers (Brain Products GmbH, Germany). We used EEGLAB to perform time-frequency analysis with a short-term Fourier transformation, and then calculated ERSP.
Outcome measures
| Measure |
Active rTMS
n=20 Participants
Active treatment will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 100 stimulation trains of 20 stimuli each (i.e., 2000 stimuli) and an inter-train interval of 9 sec. Treatment will be applied in sequential order to the left dorsolateral prefrontal cortex (DLPFC). Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
Sham rTMS
n=14 Participants
Sham rTMS stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation: The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
|
|---|---|---|
|
Event-related Spectral Perturbation (ERSP)
baseline
|
0.365 dB
Interval 0.079 to 0.706
|
0.327 dB
Interval 0.046 to 0.669
|
|
Event-related Spectral Perturbation (ERSP)
4 weeks
|
0.390 dB
Interval 0.251 to 0.721
|
0.382 dB
Interval 0.052 to 0.711
|
Adverse Events
Sham rTMS
Active rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham rTMS
n=35 participants at risk
3 subjects reported a transient headache in the initial period, After giving comfort the symptoms were significantly reduced.
No other adverse events were observed.
|
Active rTMS
n=35 participants at risk
4 subjects reported a transient headache and 1 subjects reported dizziness in the initial period.After giving comfort and reducing initial intensity of stimulation, the symptoms were significantly reduced.
No other adverse events were observed.
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|---|---|---|
|
General disorders
headache
|
8.6%
3/35 • Number of events 3 • 6 months
|
11.4%
4/35 • Number of events 4 • 6 months
|
|
General disorders
dizzsiness
|
0.00%
0/35 • 6 months
|
2.9%
1/35 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place