Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulation

ISRCTN	ISRCTN93378085
DOI	https://doi.org/10.1186/ISRCTN93378085
Secondary identifying numbers	N0071183075

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 07/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kwang Hyuk Lee
Scientific

Academic Department of Psychiatry
Longley Centre
Norwood Grange Drive
Sheffield
S5 7JT
United Kingdom

Phone	+44 (0)114 226 1511
Email	md4khl@shef.ac.uk

Study information

Study design	Pilot crossover randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulation
Study objectives	Does a new transcranial magnetic stimulation (TMS) protocol improve frontal lobe function in schizophrenia patients with severe negative symptoms during fMRI? The trialists 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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	12 patients will be randomly assigned to three different treatment conditions: 1. Prefrontal stimulation 2. Cerebellar stimulation 3. Placebo (sham) stimulation Magnetic stimulation (TBS) will occur on two successive days. Two sessions of TBS will be applied 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. 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
Primary outcome measure	Regional functional brain response measured with functional magnetic resonance imaging (fMRI)
Secondary outcome measures	A variety of standardised psychiatric ratings and neuropsychological tests
Overall study start date	15/05/2006
Completion date	14/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	12
Key inclusion criteria	1. Adult patients with schizophrenia (ages 18-55 years) 2. 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 3. All participants will be assessed for intelligence using the NART (Nelson, 1991) and handedness with Edinburgh Handedness Inventory (Oldfield, 1971)
Key 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
Date of first enrolment	15/05/2006
Date of final enrolment	14/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Department of Psychiatry

Sheffield
S5 7JT
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)207 307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sheffield Health and Social Research Consortium

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

07/07/2017: No publications found, verifying study status with principal investigator.