nTMS_NS: Navigated αTMS in Treatment-resistant Schizophrenia

Sponsor
Niuvanniemi Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01941251
Collaborator
(none)
50
1
2
129
0.4

Study Details

Study Description

Brief Summary

Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. However, previous studies have reported mixed or negative results. Majority of the repetitive transcranial magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results.

The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.

Condition or Disease Intervention/Treatment Phase
  • Device: navigated Transcranial Magnetic Stimulation
  • Device: navigated Transcranial Magnetic Stimulation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Navigated individualized αTMS

navigated Transcranial Magnetic Stimulation

Device: navigated Transcranial Magnetic Stimulation
individualized α frequency left DLPFC 110% motor threshold (MT) 13-15 sessions for 3 weeks
Other Names:
  • TMS
  • rTMS
  • Sham Comparator: Sham TMS

    navigated Transcranial Magnetic Stimulation using sham coil

    Device: navigated Transcranial Magnetic Stimulation
    - placebo treatment: sham coil
    Other Names:
  • TMS
  • rTMS
  • Outcome Measures

    Primary Outcome Measures

    1. Positive and Negative Syndrome Scale (PANSS) [at baseline,5 days after treatment, 3 months after treatment]

      change in PANSS total, positive, negative and general psychopathology sum score

    Secondary Outcome Measures

    1. Clinical Global Impression - Improvement scale (CGI-I) [at 5 days after treatment, 3 months after treatment]

      change in patient's illness relative to baseline state

    2. Neuropsychology test battery [at baseline, 5 days after treatment, 3 months after treatment]

      Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.

    Other Outcome Measures

    1. plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF) [at baseline, 1 week after treatment]

      change in P-/S-BDNF levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male righthanded inpatients, 18 to 64 years of age

    • The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV

    • Capacity and willingness to give informed consent

    • Patient is treatment-resistant, CGI-S 4 or more

    • Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment

    • No foreseeable changes in patient's smoking habits during treatment

    Exclusion Criteria:
    • Serious somatic illness

    • Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage

    • Unstable epilepsy

    • Electro convulsive therapy (ECT) less than 3 months prior to treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Niuvanniemi Hospital Kuopio Finland

    Sponsors and Collaborators

    • Niuvanniemi Hospital

    Investigators

    • Principal Investigator: Heli Tuppurainen, MD, PhD, Niuvanniemi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heli Tuppurainen, MD, PhD, Niuvanniemi Hospital
    ClinicalTrials.gov Identifier:
    NCT01941251
    Other Study ID Numbers:
    • 932012
    First Posted:
    Sep 13, 2013
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    No Results Posted as of Sep 5, 2021