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
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
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
NCT ID
NCT01941251
First Posted
September 9, 2013
Last Updated
October 12, 2022
Sponsor
Niuvanniemi Hospital
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
Learn more about this trial
Navigated αTMS in Treatment-resistant Schizophrenia
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