Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001140741
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
11/10/2013
Date last updated
11/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of the acceptability and practicability of breathing training as a therapeutic measure for psychogenic seizures
Scientific title
Is breathing training control acceptable and practicable in patients with psychogenic seizures?
Secondary ID [1] 283349 0
Nil
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychogenic seizures 290246 0
Condition category
Condition code
Neurological 290637 290637 0 0
Other neurological disorders
Mental Health 290668 290668 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breathing control training. 2 individual sessions of instruction by a respiratory physiotherapist, the first session of 60 minutes, the second session of 30 minutes one month later, with breathing exercises to carry at home, daily for 10 minutes for two months. Compliance will be recorded on seizure diaries.
Intervention code [1] 288072 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290647 0
Acceptability of breathing control training (Linkert scale)
Adverse experiences (there are no known adverse experiences from breathing control training).
Timepoint [1] 290647 0
4 months
Secondary outcome [1] 304978 0
Proportion of patients free of psychogenic seizures according to patient account and seizure diary
Timepoint [1] 304978 0
4 months, 10 months

Eligibility
Key inclusion criteria
Diagnosis of psychogenic seizures
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious respiratory disorder
Epilepsy

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)
The trial is an assessment of tolerability and acceptability, and will generate outcome data on which to base a power calculation. All patients will have the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2013
Actual
Date of last participant enrolment
Anticipated
1/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5459 0
New Zealand
State/province [1] 5459 0
Canterbury

Funding & Sponsors
Funding source category [1] 288077 0
Self funded/Unfunded
Name [1] 288077 0
Country [1] 288077 0
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Riccarton Avenue, Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 286801 0
None
Name [1] 286801 0
Address [1] 286801 0
Country [1] 286801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290004 0
HDEC New Zealand
Ethics committee address [1] 290004 0
Ethics committee country [1] 290004 0
New Zealand
Date submitted for ethics approval [1] 290004 0
07/11/2013
Approval date [1] 290004 0
Ethics approval number [1] 290004 0

Summary
Brief summary
There is evidence that poor breathing control is implicated in triggering of psychogenic seizure. We hypothesize that improving breathing control will improve psychogenic seizures. We wish to carry out a preliminary uncontrolled trial in 20 patients to establish whether breathing control training is practicable and acceptable in patients with psychogenic seizures, and to have a preliminary estimate of efficacy to inform a power calculation. Patients will have two sessions of training, with exercises to do at home, within two months of recruitment. They will be reviewed clinically at 4 and 10 months. Acceptability of breathing control training and adverse experinces will be recorded only at 4 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43434 0
A/Prof Roderick Duncan
Address 43434 0
Department of Neurology, Christchurch Hospital, Riccarton Avenue Christchurch 8011
Country 43434 0
Australia
Phone 43434 0
+6433640640
Fax 43434 0
Email 43434 0
[email protected]
Contact person for public queries
Name 43435 0
A/Prof Roderick Duncan
Address 43435 0
Department of Neurology, Christchurch Hospital, Riccarton Avenue Christchurch 8011
Country 43435 0
New Zealand
Phone 43435 0
+6433640640
Fax 43435 0
Email 43435 0
[email protected]
Contact person for scientific queries
Name 43436 0
A/Prof Roderick Duncan
Address 43436 0
Department of Neurology, Christchurch Hospital, Riccarton Avenue Christchurch 8011
Country 43436 0
New Zealand
Phone 43436 0
+6433640640
Fax 43436 0
Email 43436 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3952Plain language summaryNo We have now terminated the study, as of 31.7.15. W... [More Details]

Documents added automatically
No additional documents have been identified.