Navigated αTMS in Treatment-resistant Schizophrenia

Schizophrenia Clinical Trial

— nTMS_NS  

Official title:

Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01941251
• Other study ID #: 932012
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Niuvanniemi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• navigated Transcranial Magnetic Stimulation
individualized a frequency left DLPFC 110% motor threshold (MT) 13-15 sessions for 3 weeks
• navigated Transcranial Magnetic Stimulation
- placebo treatment: sham coil

Locations

Country	Name	City	State
Finland	Niuvanniemi Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Niuvanniemi Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)	change in P-/S-BDNF levels	at baseline, 1 week after treatment
Primary	Positive and Negative Syndrome Scale (PANSS)	change in PANSS total, positive, negative and general psychopathology sum score	at baseline,5 days after treatment, 3 months after treatment
Secondary	Clinical Global Impression - Improvement scale (CGI-I)	change in patient's illness relative to baseline state	at 5 days after treatment, 3 months after treatment
Secondary	Neuropsychology test battery	Neuropsychology test battery consists of 6 tests for measuring neurocognitive function.	at baseline, 5 days after treatment, 3 months after treatment