Trial Review

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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] 281411 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catatonia 287658 0
Condition category
Condition code
Mental Health 287996 287996 0 0
Schizophrenia
Mental Health 288111 288111 0 0
Psychosis and personality disorders
Neurological 288112 288112 0 0
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] 285901 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288204 0
Reduction in Catatonia features, based on the Bush Francis catatonia rating scale (BFCRS)
Timepoint [1] 288204 0
After each rTMS session.
Secondary outcome [1] 299603 0
Clinical evaluation using the Bush Francis catatonia rating scale (BFCRS) as used previously in rTMS studies.
Timepoint [1] 299603 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286174 0
Government body
Name [1] 286174 0
North Metropolitan Area Health Service
Country [1] 286174 0
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] 284985 0
Hospital
Name [1] 284985 0
Graylands Hospital
Address [1] 284985 0
Fitzroy House, Graylands Hospital
John XXIII Avenue
Mount Claremont, WA, 6010.
Country [1] 284985 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288240 0
North Metropolitan Area Mental Health Services Human Research Ethics Committee (EC00273)
Ethics committee address [1] 288240 0
Gascoyne House, Graylands Hospital,
John XXIII Avenue
Mount Claremont WA 6010
Ethics committee country [1] 288240 0
Australia
Date submitted for ethics approval [1] 288240 0
14/09/2012
Approval date [1] 288240 0
03/10/2012
Ethics approval number [1] 288240 0

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 34848 0
Address 34848 0
Country 34848 0
Phone 34848 0
Fax 34848 0
Email 34848 0
Contact person for public queries
Name 18095 0
Dr Greg Price
Address 18095 0
Statewide Department of Neurophysiology
Gascoyne House, Graylands Hospital,
John XXIII Avenue
Mount Claremont WA 6010
Country 18095 0
Australia
Phone 18095 0
+61 8 9347 6493
Fax 18095 0
+61 8 9384 5128
Email 18095 0
[email protected]
Contact person for scientific queries
Name 9023 0
Dr Joseph Lee
Address 9023 0
The Statewide Department of Neurophysiology
Graylands Hospital
Brockway Road
Mount Claremont WA 6010
Country 9023 0
Australia
Phone 9023 0
+61 8 9347 6801
Fax 9023 0
+61 8 9384 5128
Email 9023 0
[email protected]

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.