Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000201774
Ethics application status
Approved
Date submitted
11/02/2013
Date registered
19/02/2013
Date last updated
19/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of Neural Responses to Deep Brain Stimulation in Patients with Movement Disorders
Scientific title
For patients with movement disorders undergoing deep brain stimulation of the subthalamic nucleus, can evoked compound action potentials be measured to aid the implant procedure, programming and understanding of mechanisms of the therapy?
Secondary ID [1] 281933 0
None
Universal Trial Number (UTN)
U1111-1139-4356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Movement Disorder 288336 0
Condition category
Condition code
Neurological 288688 288688 0 0
Parkinson's disease
Neurological 288765 288765 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Recording of Evoked Compound Action Potentials during Deep Brain Stimulation of the Subthalamic Nucleus. With every stimulation pulse, nerves near the deep brain electrode respond by sending an action potential signal down the nerve. Sensitive recording equipment is used to detect and record these action potential signals as they travel past the recording electrode. The stimulation is delivered at 130 pulses/second and recording occurs on on each pulse. For this trial the stimulation and recording will take about 20 minutes.
Intervention code [1] 286495 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288838 0
Ability to record evoked neural responses (Evoked Compound Action Potentials). Sensitive stimulation and recording equipment will be used to record and display neural signals from the deep brain electrodes. With averaging (from 2 to 100 averages), any neural activity that is triggered by the stimulus (evoked responses) will become apparent in the average signal display. The primary outcome is to demonstrate that these evoked responses can be recorded in the operating room.
Timepoint [1] 288838 0
Intra-operative
Secondary outcome [1] 301097 0
Effect of changing stimulation electrode. The stimulation system will be reprogrammed to stimulate on 1 of 4 electrodes (4 electrodes/lead). Neural signals will be recorded on the remaining electrodes and changes in amplitude, latency and time course of the evoked responses will be measured.
Timepoint [1] 301097 0
Intra-operative
Secondary outcome [2] 301098 0
Effect of changing pulse width. Similar to changing electrodes, the stimulation will be reprogrammed to use 3-5 pulse widths. Neural signals will be recorded and changes in amplitude, latency and time course of the evoked responses will be measured.
Timepoint [2] 301098 0
Intra-operative
Secondary outcome [3] 301099 0
Measurement of refractory period. The stimulation system will be programmed to deliver two identical pulses with varying delays between the two - from 100 microseconds to 5 milliseconds. The amplitude of the evoked response to the second pulse will be measured. At short delays, the 2nd response will not occur (absolute refractory period) and as the delay gets longer the 2nd response will begin to grow (relative refractory period) back to control amplitudes.
Timepoint [3] 301099 0
Intra-operative
Secondary outcome [4] 301100 0
Measurement of evoked compound action potentials and local field potentials during movement. During stimulation, evoked responses will be measured as the Neurologist passively moves the patients limbs and when the patient actively moves their limbs. Changes in amplitude, latency and time course of the evoked potentials will be measured. Additionally, non-evoked background neural activity (local field potentials) will be measured during the above manoeuvres and changes in amplitude and frequency content of the neural signal measured.
Timepoint [4] 301100 0
Intra-operative

Eligibility
Key inclusion criteria
Patients medically assessed as suitable candidates for Deep Brain Stimulation (DBS) for movement disorders.
Patients implanted with a commercially available electrode lead into the STN who are part of a routine DBS implant procedure.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had complications during implantation such that the implanted electrodes are not able to stimulate and record in the STN

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/03/2013
Actual
Date of last participant enrolment
Anticipated
30/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 567 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 6303 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 286717 0
Other Collaborative groups
Name [1] 286717 0
National ICT Australia Ltd
Country [1] 286717 0
Australia
Funding source category [2] 286718 0
University
Name [2] 286718 0
Asia-Pacific Centre for Neuromodulation
Country [2] 286718 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National ICT Australia Ltd
Address
Level 5
13 Garden St
Eveleigh NSW 2015
Country
Australia
Secondary sponsor category [1] 285491 0
None
Name [1] 285491 0
Address [1] 285491 0
Country [1] 285491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288784 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 288784 0
PO Box 499
TOOWONG QLD 4066
Ethics committee country [1] 288784 0
Australia
Date submitted for ethics approval [1] 288784 0
Approval date [1] 288784 0
06/12/2012
Ethics approval number [1] 288784 0
1228
Ethics committee name [2] 288785 0
St Andrew's Medical Institute Research Committee
Ethics committee address [2] 288785 0
GPO Box 764
Brisbane QLD 4001
Ethics committee country [2] 288785 0
Australia
Date submitted for ethics approval [2] 288785 0
Approval date [2] 288785 0
11/12/2012
Ethics approval number [2] 288785 0
N/A

Summary
Brief summary
The central aim of the study is to determine if Evoked Compound Action Potentials (ECAPs) can be recorded during Deep Brain Stimulation (DBS). During the DBS lead implant procedure, specialised stimulating and recording equipment will be connected to the lead. Routine stimulation will be applied to the implanted lead electrodes and neural responses (ECAPs) will be recorded from the adjacent electrodes. Measurement of the ECAP responses may provide information to improve the implant procedure and stimulation programming, and provide information on the mechanisms of DBS.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 37762 0
Prof Peter Silburn
Address 37762 0
St Andrew’s War Memorial Hospital
457 Wickham Terrace
BRISBANE QLD 4000
Country 37762 0
Australia
Phone 37762 0
+61 7 3346 5551
Fax 37762 0
Email 37762 0
[email protected]
Contact person for public queries
Name 37763 0
Prof Helen Chenery
Address 37763 0
Asia-Pacific Centre for Neuromodulation
UQ Centre for Clinical Research
Building 71/918
Herston QLD 4029
Country 37763 0
Australia
Phone 37763 0
+61 7 3346 5551
Fax 37763 0
Email 37763 0
[email protected]
Contact person for scientific queries
Name 37764 0
Dr Robert Gorman
Address 37764 0
NICTA
Level 5
13 Garden St
Eveleigh NSW 2015
Country 37764 0
Australia
Phone 37764 0
+61 2 9376 2251
Fax 37764 0
Email 37764 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.