Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
03/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes