Navigated αTMS in Treatment-resistant Schizophrenia

Not Applicable

Active, not recruiting

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Device: navigated Transcranial Magnetic Stimulation

• Registration Number: NCT01941251
• Lead Sponsor: Niuvanniemi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2016-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigated individualized αTMS	navigated Transcranial Magnetic Stimulation	navigated Transcranial Magnetic Stimulation
Sham TMS	navigated Transcranial Magnetic Stimulation	navigated Transcranial Magnetic Stimulation using sham coil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Neuropsychology test battery	at baseline, 5 days after treatment, 3 months after treatment	Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.

Trial Locations

Locations (1)

Niuvanniemi Hospital; 🇫🇮 Kuopio, Finland