Navigated αTMS in Treatment-resistant Schizophrenia

NCT01941251 | Unknown

• 1 other identifier: 932012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Transcranial Magnetic Stimulation; Repetitive Transcranial Magnetic Stimulation; Schizophrenia; Schizoaffective Disorder; Treatment; Negative Symptoms; Positive Symptoms; TMS; rTMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Global Impression - Improvement scale (CGI-I)

  at 5 days after treatment, 3 months after treatment

• Neuropsychology test battery

  at baseline, 5 days after treatment, 3 months after treatment

Other Outcomes (1)

• plasma and serum levels of Brain Derived Neurotrophic Factor (P-/S-BDNF)

  at baseline, 1 week after treatment

Study Arms (2)

Navigated individualized αTMS

ACTIVE COMPARATOR

navigated Transcranial Magnetic Stimulation

Device: navigated Transcranial Magnetic Stimulation

Sham TMS

SHAM COMPARATOR

navigated Transcranial Magnetic Stimulation using sham coil

Device: navigated Transcranial Magnetic Stimulation

Interventions

navigated Transcranial Magnetic Stimulation DEVICE

* individualized α frequency * left DLPFC 110% motor threshold (MT) * 13-15 sessions for 3 weeks

Also known as: TMS, rTMS

Navigated individualized αTMS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Niuvanniemi Hospital: lead

Study Sites (1)

Niuvanniemi Hospital

Kuopio, Finland

Location

Related Publications (1)

• Tuppurainen H, Maatta S, Kononen M, Julkunen P, Kautiainen H, Hyvarinen S, Vaurio O, Joensuu M, Vanhanen M, Aho-Mustonen K, Mervaala E, Tiihonen J. Navigated and individual alpha-peak-frequency-guided transcranial magnetic stimulation in male patients with treatment-refractory schizophrenia. J Psychiatry Neurosci. 2024 Mar 1;49(2):E87-E95. doi: 10.1503/jpn.230063. Print 2024 Jan-Feb.

  PMID: 38428970 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Heli Tuppurainen, MD, PhD

  Niuvanniemi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 13, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

FI (1)