None listed
Conditions
Brief summary
Auditory hallucinations (AH) are one of the most common and distressing symptoms of schizophrenia, occurring in more than 70% of patients. Whilst the primary form of treatment for AH is antipsychotic medications, a significant proportion (30-40%) of patients fail to respond significantly to pharmacological therapy. Novel treatment options are therefore needed. A substantial body of evidence suggests that auditory hallucinations may be improved with repetitive Transcranial Magnetic Stimulation (rTMS), although in these studies, and in our clinical experience, only a small proportion of patients respond to this treatment. The majority of studies which have demonstrated modest response rates to rTMS for AH have used a relatively standard approach for targeting the brain regions believed to be implicated in AH; namely, the 10–20 EEG system for localising the left temporoparietal cortex. It is therefore reasonable to propose that by more accurately targeting brain regions implicated in AH for each individual patient, a greater reduction in the intensity and frequency of AH may be observed. We propose to investigate this using neuro-navigational methods combined with resting state functional connectivity MRI-based scanning to more precisely pinpoint the site of stimulation in individual patients. We will recruit participants with a diagnosis with schizophrenia or schizoaffective disorder who experience auditory hallucinations, and they will undergo a resting state MRI scan prior to treatment. They will then receive rTMS treatment either based on an analysis of their MRI scan, or treatment localised using the standard 10-20 EEG method. This study has the potential to substantially contribute to the development of rTMS as a new therapeutic tool for treatment-resistant auditory hallucinations.
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS is a non-invasive technique for stimulating neural tissue. A rapid change in magnetic field induces a current in the neural tissue. If the current is of sufficient amplitude and duration it will excite nerve tissues.
In the current study we aim to determine whether neuro-navigationally targeted rTMS applied to the temporal cortex will reduce the intensity and frequency of auditory hallucinations to a greater degree than rTMS applied to t
Repetitive Transcranial Magnetic Stimulation (rTMS) rTMS is a non-invasive technique for stimulating neural tissue. A rapid change in magnetic field induces a current in the neural tissue. If the current is of sufficient amplitude and duration it will excite nerve tissues. In the current study we aim to determine whether neuro-navigationally targeted rTMS applied to the temporal cortex will reduce the intensity and frequency of auditory hallucinations to a greater degree than rTMS applied to the standard temporoparietal 10-20 EEG (TP3) site. Participants will initially be randomised to receive rTMS treatment either based on an analysis of their MRI scan, or treatment localised using the traditional 10-20 EEG site method. Prior to the commencement of the treatment course, motor threshold (MT) will be measured with single pulse TMS applied to the motor cortex. The treatment course will consist of 20 treatment sessions conducted daily (Mon-Fri). During each session, one continuous train of 20 minutes duration will be applied at 120% of motor threshold. Patients who do not achieve an adequate treatment response in this first phase will be crossed over to the alternate condition and offered a second treatment course. No washout period will be required before commencing in the second phase of treatment. Patients who have experienced any reduction in symptom severity during either arm of the crossover trial will be offered participation in an open label phase.
Sponsors
Professor Paul Fitzgerald
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder; Are aged 18-75; Experience auditory hallucinations that rate a minimum of 4 (moderate) on the PANSS auditory hallucinations item and are present at least on a daily basis; Have failed to respond to a minimum of 2 adequate trials of antipsychotic medication; Have demonstrated capacity to give informed consent.
Exclusion criteria
Have a history of epilepsy or baseline EEG abnormalities; Have a significant or unstable neurological disorder or a cardiac pacemaker; Have had a previous brain injury or neurosurgery, or have any metal clips, plates or other metal items in the head; Are currently pregnant or lactating; Are a professional driver; Have a history of substance abuse or dependence in the last 6 months, as determined by the DSM-IV.
Outcome results
None listed