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Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

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ClinicalTrials.gov Identifier: NCT02842034
Recruitment Status : Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Condition or disease Intervention/treatment
Schizophrenia Device: Repetitive Transcranial Magnetic Stimulation

Detailed Description:
The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active rTMS
Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC).
Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
Sham Comparator: Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the same 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.
Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.



Primary Outcome Measures :
  1. Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale) [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]

Secondary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  2. Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS] [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  3. Change from baseline in clinical global impression [CGI] [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  4. Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0] [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  5. Change from baseline in Simpson-Angus Scale [SAS] [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  6. Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS] [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]

Other Outcome Measures:
  1. Change from baseline in Letter-Number Span [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  2. Change from baseline in Wechsler Working Memory [ Time Frame: 3 times (Before treatment,immediately after treatment,4 weeks after treatment) ]
  3. Change from baseline in Resting-state functional MRI:TR=2000 ms,TE=35 ms,FA=90,Matrix =64×64,Nex=1,FOV=256 mm,thickness=4 mm,Gap=0,scanning 33 slices。 [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  4. Change from baseline in diffusion tensor imaging (DTI):TR=8500,TE=87, matrix size=64×64, FOV=230, slices thickness = 3 mm, diff directions=30,scanning 46 slices [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  5. Change from baseline in Magnetic Resonance Spectroscopy (MRS) of DMPFC [ Time Frame: 2 times (Before treatment,immediately after treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis of schizophrenia according to DSM-IV;
  • 18~55 years old;
  • schizophrenic illness duration longer than one year;
  • The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
  • Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
  • Able to adhere to the treatment schedule;
  • IQ≥80;
  • Dextromanual, normal vision and hearing;
  • Signed an informed consent

Exclusion Criteria:

  • rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
  • Acute risk of suicide and impulse;
  • patients to be diagnosed according to DSM-IV for substance abused, development delayed;
  • suffering from serious physical disease and can not accept the treatment;
  • history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
  • difficult to maintain the current drug treatment for at least 1 month;
  • undergoing ECT or MECT in last 3 months;
  • current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842034


Contacts
Contact: Dengtang Liu, MD +86 21 64387250-73775 erliu110@126.com

Sponsors and Collaborators
Shanghai Mental Health Center

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02842034     History of Changes
Other Study ID Numbers: rTMS-negative symptoms
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: June 2016

Keywords provided by Shanghai Mental Health Center:
schizophrenia
rTMS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders