ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12612001174875

Ethics application status

Approved

Date submitted

18/10/2012

Date registered

6/11/2012

Date last updated

6/11/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Repetitive Transcranial Magnetic Stimulation in the treatment of Catatonia

Scientific title

For patients with Catatonia, can repetitive Transcranial Magnetic Stimulation (rTMS), affect the symptoms and presentation of the illness.

Secondary ID [1]

Nil.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Catatonia

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Repetitive Transcranial Magnetic Stimulation (rTMS).
This clinical trial will be conducted with a single arm of rTMS, with the standard arm parameters used derived from our estimate of best practice. A MagStim Rapid magnetic stimulator (Magstim, Whitland, UK), connected with a figure-of-eight coil with a diameter of 70mm, will be used to deliver stimuli with the coil handle pointing posteriorly and 45degrees below the coronal plane.
Prior to the commencement of the treatment course, resting motor threshold is measured with single-pulse TMS applied to the motor cortex. The resting motor threshold was measured as the minimal stimulator intensity producing a visible peripheral motor evoked potential response by inspection.
A total of 2000 pulses (40 trains) will be delivered in a session (20 minutes). 10Hz for 5 seconds, with 25 second break between trains. Intensity is set at 100% of magnetic threshold. Application over the left dorsolateral prefrontal cortex (LDPFC)
Daily sessions will continue up to a maximum of 10 (2 weeks, 20000 pulses).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Reduction in Catatonia features, based on the Bush Francis catatonia rating scale (BFCRS)

Timepoint [1]

After each rTMS session.

Secondary outcome [1]

Clinical evaluation using the Bush Francis catatonia rating scale (BFCRS) as used previously in rTMS studies.

Timepoint [1]

After 10 sessions, or on withdrawal from the trial.

Eligibility

Key inclusion criteria

DSM-IV diagnosis of catatonia. Subsequent catatonia scale scores will act as a validation check (any discrepancies to be reviewed by CI), but initial inclusion will be purely by clinical diagnosis.

Minimum age

18 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of cardiac pacemakers, medication pumps, cochlear implants or metal objects in the head or eyes that could be dangerous if heated or moved by the magnetic pulses.
Significant medical illness, substantial risk of suicide, current substance dependence, a history of seizures, epilepsy, stroke or major head trauma, or a history of alcohol dependence.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

As Introduced, the requirements for timely standard treatment attempts restricts the scope for application of rTMS.clinical. Standard medication must have been attempted with unsatisfactory results. In addition, the application of ECT must have been considered. Unsuccessful ECT would likely indicate that rTMS will have similar or less effect. These chronic cases will be recruited, but rTMS investigations would probably be most informative in those cases where ECT is not possible for other reasons. Clearly these cases will be reported separately. Written documentation of previous treatment attempts will be included.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

North Metropolitan Area Health Service

Address [1]

Statewide Department of Neurophysiology
Gascoyne House, Graylands Hospital
John XXIII Avenue
Mount Claremont, WA, 6010.

Country [1]

Australia

Primary sponsor type

Government body

Name

North Metropolitan Area Health Service

Address

Statewide Department of Neurophysiology
Gascoyne House, Graylands Hospital
John XXIII Avenue
Mount Claremont, WA, 6010.

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Graylands Hospital

Address [1]

Fitzroy House, Graylands Hospital
John XXIII Avenue
Mount Claremont, WA, 6010.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Metropolitan Area Mental Health Services Human Research Ethics Committee (EC00273)

Ethics committee address [1]

Gascoyne House, Graylands Hospital,
John XXIII Avenue
Mount Claremont WA 6010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/09/2012

Approval date [1]

03/10/2012

Ethics approval number [1]

Summary

Brief summary

Catatonia is a neuropsychiatric syndrome that can occur due to medical or psychiatric disorder. It is a behavioral syndrome that can be associated with schizophrenia, shizoaffective disorder, or atypical psychosis.
ECT was found to be effective for both catatonic stupor and excitement, where benzodiazepine or neuroleptics may not prove successful, and has proven to increase intracortical inhibition (ICI) which is reduced in patients with schizophrenia. Since TMS has been shown to alter cortical excitability, this provides a rationale for moving from ECT to TMS based treatment. Essentially arguing by analogy with ECT, and its effect in depression, three case reports appear to show an ECT-like effect of rTMS in catatonic schizophrenia. All studies used facilitatory fast rTMS (10Hz and 20Hz) although on opposite sides of the prefrontal cortex.
In this study we will replicate the best practice application of rTMS in the treatment of catatonia. Since this paradigm is similar to an existing treatment for depression at our unit, no additional preparation is required. As suitable participants are expected to be uncommon, a case series approach will allow us to recruit opportunistically, over an extended period, as clinically warranted. Findings will be reported as a series of case studies, or accumulated as a case series report, depending on the number of cases.
This is a fairly novel application of rTMS, but builds on our unit’s experience with rTMS, and Dr Lee’s previous experience in catatonia research, to contribute to this emerging field. The objective is to answer two questions. Whether rTMS will affect catatonia, and what are the clinical circumstances that indicate rTMS treatment. A series of case findings will give an indication of an answer, and inform local treatment consideration.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Greg Price

Address

Statewide Department of Neurophysiology
Gascoyne House, Graylands Hospital,
John XXIII Avenue
Mount Claremont WA 6010

Country

Australia

Phone

+61 8 9347 6493

Fax

+61 8 9384 5128

Greg.Price@health.wa.gov.au

Contact person for scientific queries

Name

Dr Joseph Lee

Address

The Statewide Department of Neurophysiology
Graylands Hospital
Brockway Road
Mount Claremont WA 6010

Country

Australia

Phone

+61 8 9347 6801

Fax

+61 8 9384 5128

Joseph.Lee@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically