Schizophrenia Clinical Trial
Official title:
Treating Working Memory Deficits in Patients With Schizophrenia Using Repetitive Transcranial Magnetic Stimulation (rTMS)
Verified date | June 2013 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Deficits in working memory (WM) performance are the most significant cognitive impairments
in schizophrenia (SCZ). It has also been shown that WM performance is contingent on the
cortex synchronization, a process that relies on brain inhibition. Repetitive Transcranial
Magnetic Stimulation (rTMS) has been demonstrated as an effective treatment for patients
with SCZ and has been shown to increase brain inhibition and improve cognitive performance.
In this study the investigators intend to:
- evaluate rTMS as a treatment for WM deficits in SCZ
- evaluate rTMS as a method to increase WM performance in healthy individuals
- determine if improvements in WM performance are related to enhanced synchronization of
brain networks
- determine whether genetic polymorphisms predict cortical function and treatment
response
- evaluate the influence of rTMS treatment on brain structure.
Status | Completed |
Enrollment | 122 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria for Schizophrenia Subjects: - Voluntary and competent to consent - SCID-IV Diagnosis of Schizophrenia or Schizoaffective Disorder - Between the ages of 18 and 85 Inclusion Criteria for Healthy Subjects: - voluntary and competent to consent - between the ages of 18-85 - considered a healthy individual free of psychopathology based on the Personality Assessment Inventory - right-handed determined by the TMS screening and demographic form - self-reported non-smoker - do not have a self-reported concomitant major medical or neurologic illness - if a woman of childbearing potential, must be on an effective means of birth control determined through completion of the TMS screening and demographic form. Exclusion Criteria for both Healthy Controls and Schizophrenia Subjects: - Have a DSM-IV history of substance abuse or dependence in the last 6 months - Have a concomitant major and unstable medical or neurologic illness - Have a history of seizures - Have a first degree relative with a history of a seizure disorder - Are pregnant - Have any clinically significant EEG activity indicating an increased risk of seizure, as confirmed by a neurologist. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure will be the performance on the N-back working memory task. | Specifically, we will evaluate if rTMS results in changes to the number of correct answers, omissions and errors as well as reaction times. | 4 weeks | No |
Secondary | Increase in gamma band synchrony | To ascertain whether high frequency rTMS is superior to sham stimulation in increasing gamma band synchrony our analysis will examine stimulus-locked changes in spectral power, phase, and coherence between electrodes. | 4 weeks | No |
Secondary | Brain Imaging Changes | For brain imaging we will test for group differences using: (1) cortical thickness (2) volumetric measures, (3)diffusion based measures. Statistical tests measuring these differences will be conducted at baseline and at the conclusion of the study. We will control for possible effects of neuroleptic medication on MRI measures by regressing mean dosage levels multiplied by number of years on medication, for each of five classes of medication (typical neuroleptics, atypical neuroleptics, antiparkinsonian anticholinergics, lithium, benzodiazepines) | 4 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |