Contact information
Type
Scientific
Primary contact
Dr Kwang Hyuk Lee
ORCID ID
Contact details
Academic Department of Psychiatry
Longley Centre
Norwood Grange Drive
Sheffield
S5 7JT
United Kingdom
+44 (0)114 226 1511
md4khl@shef.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0071183075
Study information
Scientific title
Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulation
Acronym
Study hypothesis
Does a new transcranial magnetic stimulation (TMS) protocol improve frontal lobe function in schizophrenia patients with severe negative symptoms during fMRI?
Ethics approval
Not provided at time of registration
Study design
Pilot crossover randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mental and Behavioural Disorders: Schizophrenia
Intervention
We hypothesise that rTMS over the prefrontal cortex and cerebellum using a recently developed protocol (TBS) has a therapeutic effect in patients with schizophrenia via the improvement of frontal lobe function, compared with sham (placebo) treatment.
We will utilise a double-blind randomised controlled design. We will invite 12 adult patients with schizophrenia who have severe negative symptoms. There will be three different treatment conditions:
1. Prefrontal stimulation
2. Cerebellar stimulation and
3. Placebo (sham) stimulation
We will use a direct measure of brain activation (ie fMRI) as a primary outcome measure.
This study will have received approval by Local Research Ethics Committee.
Magnetic stimulation (TBS) will occur on two successive days. We will apply two sessions of TBS over two successive days (one in day 2, and one just before fMRI in day 3) for each arm (frontal, cerebellar, and sham). Each TBS session (real or sham conditions) comprises two 40-second TBSs with a 10-min break. Patients will undergo symptom, cognitive and psychosocial assessments, before and after the TBS treatment. Throughout the study, all subjects will continue to receive standard care from their responsible consultant psychiatrist.
12 patients will be randomly assigned into three groups. Before starting TBS, patients will undergo:
1. A medical and psychiatric evaluation
2. Neuropsychological tests to assess concentration and memory abilities and
3. An fMRI brain scan
Patients will receive either real TBS (to the prefrontal cortex or cerebellum) or placebo TBS for approximately 15 minutes (including 10-min break) per day over two successive days.
After treatment, psychiatric evaluation, neuropsychological testing, and fMRI scan will be repeated. TBS treatment and neuropsychological testing will take place within the Academic Unit of Radiology, Royal Hallamshire Hospital, where the MRI scanner is located. If, after the completion of the study, it was determined that TBS was effective in improving cognitive test performance or reducing the severity of psychiatric symptoms, patient who received placebo stimulation will be offered a trial of real rTMS after consulting their responsible consultant psychiatrist.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Regional functional brain response measured with Functional magnetic resonance imaging (fMRI)
Secondary outcome measures
A variety of standardised psychiatric ratings and neuropsychological tests will be used as secondary outcome measures.
Overall trial start date
15/05/2006
Overall trial end date
14/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
The proposed study involves patients with schizophrenia only. Adult patients with schizophrenia (ages 18-55 years). Patients will be screened with the Schedule for the Assessment of Negative Symptoms (SANS) (Andreasen, 1983). Patients with severe negative symptoms (defined by score of ≥ 3 in any of SANS sub-scales) will be recruited for this study. All participants will be assessed for intelligence using the NART (Nelson, 1991) and handedness with Edinburgh Handedness Inventory (Oldfield, 1971).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. History of neurological disorder including seizures
2. General medical conditions likely to impair cortical function or haemodynamic response (hypertension or diabetes)
3. Metallic implants (and other contraindications to MR procedures)
4. Established drug or alcohol dependency disorders
5. Estimated IQ less than 75
6. Inability to give an informed consent.
Recruitment start date
15/05/2006
Recruitment end date
14/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Department of Psychiatry
Sheffield
S5 7JT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)207 307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sheffield Health and Social Research Consortium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary