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Navigated αTMS in Treatment-resistant Schizophrenia (nTMS_NS)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
navigated Transcranial Magnetic Stimulation
navigated Transcranial Magnetic Stimulation
Sponsored by
Niuvanniemi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Positive Symptoms, TMS, rTMS

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Niuvanniemi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Navigated individualized αTMS

Sham TMS

Arm Description

navigated Transcranial Magnetic Stimulation

navigated Transcranial Magnetic Stimulation using sham coil

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS)
change in PANSS total, positive, negative and general psychopathology sum score

Secondary Outcome Measures

Clinical Global Impression - Improvement scale (CGI-I)
change in patient's illness relative to baseline state
Neuropsychology test battery
Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.

Full Information

First Posted
September 9, 2013
Last Updated
October 12, 2022
Sponsor
Niuvanniemi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01941251
Brief Title
Navigated αTMS in Treatment-resistant Schizophrenia
Acronym
nTMS_NS
Official Title
Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Niuvanniemi Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Positive Symptoms, TMS, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigated individualized αTMS
Arm Type
Active Comparator
Arm Description
navigated Transcranial Magnetic Stimulation
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
navigated Transcranial Magnetic Stimulation using sham coil
Intervention Type
Device
Intervention Name(s)
navigated Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS, rTMS
Intervention Description
individualized α frequency left DLPFC 110% motor threshold (MT) 13-15 sessions for 3 weeks
Intervention Type
Device
Intervention Name(s)
navigated Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS, rTMS
Intervention Description
- placebo treatment: sham coil
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
change in PANSS total, positive, negative and general psychopathology sum score
Time Frame
at baseline,5 days after treatment, 3 months after treatment
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement scale (CGI-I)
Description
change in patient's illness relative to baseline state
Time Frame
at 5 days after treatment, 3 months after treatment
Title
Neuropsychology test battery
Description
Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.
Time Frame
at baseline, 5 days after treatment, 3 months after treatment
Other Pre-specified Outcome Measures:
Title
plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)
Description
change in P-/S-BDNF levels
Time Frame
at baseline, 1 week after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heli Tuppurainen, MD, PhD
Organizational Affiliation
Niuvanniemi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Niuvanniemi Hospital
City
Kuopio
Country
Finland

12. IPD Sharing Statement

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Navigated αTMS in Treatment-resistant Schizophrenia

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