Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulation
| ISRCTN | ISRCTN93378085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93378085 |
| Protocol serial number | N0071183075 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Sheffield Health and Social Research Consortium, NHS R&D Support Funding |
- 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
Scientific
Academic Department of Psychiatry
Longley Centre
Norwood Grange Drive
Sheffield
S5 7JT
United Kingdom
| Phone | +44 (0)114 226 1511 |
|---|---|
| md4khl@shef.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot crossover randomised controlled study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
Regional functional brain response measured with functional magnetic resonance imaging (fMRI) |
| Key secondary outcome measure(s) |
A variety of standardised psychiatric ratings and neuropsychological tests |
| Completion date | 14/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Academic Department of Psychiatry
Sheffield
S5 7JT
United Kingdom
S5 7JT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/07/2017: No publications found, verifying study status with principal investigator.
