Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01940939
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Device: Repetitive Transcranial Magnetic Stimulation
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 35 35
Completed 33 27
Not Completed 2 8
Reason Not Completed
Withdrawal by Subject             2             8
Arm/Group Title Active rTMS Sham rTMS Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
35
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
13
  37.1%
10
  28.6%
23
  32.9%
Male
22
  62.9%
25
  71.4%
47
  67.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
35
 100.0%
35
 100.0%
70
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title The Change in the Severity of Negative Symptoms
Hide Description 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.
Time Frame Baseline, after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 33 27
Mean (Full Range)
Unit of Measure: units on a scale
SANS(Baseline)
48.09
(31 to 78)
50.33
(35 to 91)
SANS(4 weeks)
33.91
(23 to 54)
41.00
(24 to 70)
PANSS(Baseline)
68.15
(60 to 82)
69.93
(61 to 82)
PANSS(4 weeks)
54.58
(40 to 73)
59.85
(48 to 76)
2.Secondary Outcome
Title MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version
Hide Description 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.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 33 27
Mean (Standard Deviation)
Unit of Measure: MCCB(T score)
Composite score (baseline) 45.07  (6.48) 43.58  (9.25)
Composite score (4 weeks) 48.00  (7.16) 49.04  (7.46)
3.Other Pre-specified Outcome
Title Event-related Spectral Perturbation (ERSP)
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients discontinualed treatment
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 20 14
Mean (Full Range)
Unit of Measure: dB
baseline
0.365
(0.079 to 0.706)
0.327
(0.046 to 0.669)
4 weeks
0.390
(0.251 to 0.721)
0.382
(0.052 to 0.711)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham rTMS Active rTMS
Hide Arm/Group Description

3 subjects reported a transient headache in the initial period, After giving comfort the symptoms were significantly reduced.

No other adverse events were observed.

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.

All-Cause Mortality
Sham rTMS Active rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sham rTMS Active rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham rTMS Active rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/35 (8.57%)      5/35 (14.29%)    
General disorders     
headache   3/35 (8.57%)  3 4/35 (11.43%)  4
dizzsiness   0/35 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ShanghaiMHC
Organization: Dr.LIU
Phone: 862134773775
Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01940939     History of Changes
Other Study ID Numbers: 11ZR1431600
First Submitted: September 9, 2013
First Posted: September 12, 2013
Results First Submitted: May 4, 2016
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018