Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

NCT01551979 | Completed Results

• 1 other identifier: 2011P000373
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies. If the investigators trial were to show beneficial effects, its clinical significance would be great.

Conditions

Schizophrenia

Keywords

Schizophrenia; repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (5)

• Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale

  Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.

  Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

• Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale

  Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.

  Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

• Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale

  Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.

  Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

• Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness

  Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.

  Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

• Clinical Global Impression (CGI) Global Improvement

  Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.

  Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

Secondary Outcomes (1)

• Change From Baseline on the Calgary Depression Scale for Schizophrenia

  Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham rTMS to the vermis (lobule VII) of the cerebellum.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session. Sham participants will undergo the same procedures as those in the active rTMS group.

Also known as: Transcranial Magnetic Stimulation, Noninvasive Brain Stimulation

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years
• Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical Manual) by a board-certified psychiatrist

You may not qualify if:

• Preexisting or progressive neurological disorders
• Prior neurological procedures
• Previous head injury
• Change in antipsychotic medication during the last 4 weeks
• Been an inpatient in a psychiatry clinic within the last month
• Any other axis 1 diagnosis
• Patients may not be actively enrolled in a separate intervention study
• Patients unable to undergo a brain MRI
• Any unstable medical condition
• History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform\_ EEG, or family history of treatment resistant epilepsy
• Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test.
• Any metal in the brain, skull, or elsewhere unless approved by the responsible MD
• Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
• Substance abuse (alcohol, amphetamines, cocaine, MDMA \[methylenedioxymethamphetamine\], ecstasy, PCP \[phencyclidine\], Angle dust) or dependence within the past six months

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Sidney R. Baer, Jr. Foundation: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02134, United States

Location

Related Publications (24)

• Batini C, Buisseret-Delmas C, Corvisier J, Hardy O, Jassik-Gerschenfeld D. Brain stem nuclei giving fibers to lobules VI and VII of the cerebellar vermis. Brain Res. 1978 Sep 22;153(2):241-61. doi: 10.1016/0006-8993(78)90405-5.

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Related Links

• Related Information

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Mark Halko
• Organization: Beth Israel Deaconess Medical Center

mhalko@bidmc.harvard.edu

6176670367

Study Officials

• Mark Halko, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Neurology

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 13, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 12, 2018
• Results First Posted: June 2, 2017

Record last verified: 2018-03

Locations

US (1)