| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN93378085 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0071183075 |
| Public title | Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulation |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: Schizophrenia |
| Study hypothesis | Does a new transcranial magnetic stimulation (TMS) protocol improve frontal lobe function in schizophrenia patients with severe negative symptoms during fMRI? |
| Design/methodology | Pilot crossover randomised controlled study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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). |
| Participants - 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. |
| Patient information material |
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| Anticipated start date | 15/05/2006 |
| Anticipated end date | 14/05/2008 |
| Status of trial | Ongoing |
| Target number of participants | 12 |
| Interventions | 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. |
| Primary outcome measure(s) | Regional functional brain response measured with Functional magnetic resonance imaging (fMRI) |
| Secondary outcome measure(s) | A variety of standardised psychiatric ratings and neuropsychological tests will be used as secondary outcome measures. |
| Sources of funding | Sheffield Health and Social Research Consortium
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Kwang Hyuk Lee |
| Contact details | Academic Department of Psychiatry
Longley Centre
Norwood Grange Drive
Sheffield
United Kingdom
S5 7JT |
| Contact telephone | +44 0114 226 1511 |
| Contact fax | +44 0114 226 1522 |
| Contact email | md4khl@shef.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN93378085 |
| Date last extracted from ISRCTN register | 17/04/2008 |
