Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001217998
Ethics application status
Approved
Date submitted
17/08/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating brain waves during spinal cord stimulation
Scientific title
Investigating spinal cord stimulation using electroencephalography in chronic pain patients with a spinal cord stimulator implant
Secondary ID [1] 302037 0
None
Universal Trial Number (UTN)
U1111-1238-2486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 318644 0
Condition category
Condition code
Neurological 316657 316657 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Although we will not be implanting SCS in any participant, we will be asking participants to activate their existing SCS implant in a systematic (but safe) manner that they probably would not have otherwise.

Recordings will be taken in a single session, lasting approximately 90 minutes, at the Auckland Regional Pain Service. We expect the actual recording period to be about 30 minutes.

With the input of the patient and a registered nurse experienced in the programming procedure (ED), we will add six experimental programs to the patient’s controller, with pulse frequencies of 15Hz, 25Hz, and 35Hz. Pulse width will be 300µs. At each frequency, stimulation amplitude will be increased in steps from zero until the patient just perceives paraesthesia, and then go several steps above that. This will give us three perceptible stimulation patterns. At each frequency we will program a non-perceptible stimulation pattern a few steps below the threshold of perceptibility, for six total experimental programs. We will program each stimulation pattern to activate for 4 seconds every 10 seconds. When the stimulation program is activated, it fires immediately. The response to the first stimulation is unlikely to be analysed (there will be no baseline beforehand), but will be for the participant to confirm that he/she wants to continue.
Before each block, one of the six stimulation programs will be selected randomly by computer. This program will then be activated using the controller by the participant, and interrupted after four activations (i.e. one block), either by the experimenter or participant. The participant will have access to a deactivation button at all times, and will be encouraged to use it if they want to cease stimulation for any reason.

After each block of four trials, we will ask the participant to record his/her comfort level on a visual analogue scale, give him/her an opportunity to elect to discontinue, and adjust the stimulation program in the case of continuation. We aim to collect data from 72 trials in 18 blocks, but will stop if at any point the participant requests so.
Intervention code [1] 318351 0
Treatment: Devices
Comparator / control treatment
Within participants, comparison of EEG trace during four seconds of stimulation to the preceding baseline period during which stimulation was off.
Control group
Active

Outcomes
Primary outcome [1] 324782 0
Presence or absence of stimulus artefact on EEG trace during SCS
Timepoint [1] 324782 0
During SCS
Primary outcome [2] 325675 0
High-level description of any stimulus artefact on EEG trace during SCS
Timepoint [2] 325675 0
During SCS
Primary outcome [3] 325676 0
High-level description of the EEG trace during SCS
Timepoint [3] 325676 0
During SCS
Secondary outcome [1] 385725 0
EEG power at tonic SCS frequency assessed by EEG and epidermal electrode data.
Timepoint [1] 385725 0
At EEG recording session
Secondary outcome [2] 385726 0
Spatial arrangement of SCS response
We will present scalp maps of key points in the time and time-frequency domain data.
Timepoint [2] 385726 0
At EEG recording session
Secondary outcome [3] 385727 0
Description of SCS artefact recorded at epidermal electrodes placed over the SCS electrode and pulse generator site
Timepoint [3] 385727 0
At EEG recording session

Eligibility
Key inclusion criteria
1. Age 18+ years old
2. Operational SCS implant
3. No surgery at implant site in at least three months
4. Willing to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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)
Each block will be involve four trials administering a particular combination of frequency (15Hz, 25Hz, or 35Hz) and perceptibility (perceptible or subperception). The six combinations will each be presented three times, in random order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Within-participants
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To test our signal-related hypotheses, we plan to use the filter-Hilbert time-frequency decomposition on EEG and epidermal electrode data. Spectral power values at the SCS frequency converted to Z-values using a pre-stimulation baseline. Thus, a Z-value over 1.96 at the relevant frequency will indicate significant (i.e. two-tailed 95%) facilitation in the relevant frequency band.
We do not yet know what the stimulus artefact (i.e. non-biological) component of the EEG signal will be (or if it exists, for that matter), but we will investigate techniques for isolating and ameliorating it. It is difficult to say what this artefact-correction procedure will look like a priori, and our analysis methods may change in response to the outcomes of this process. This uncertainty about the electrophysiological signature of SCS also renders it unfeasible to perform statistical power calculations for this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 22855 0
New Zealand
State/province [1] 22855 0
Auckland

Funding & Sponsors
Funding source category [1] 306457 0
Charities/Societies/Foundations
Name [1] 306457 0
Neurological Foundation of New Zealand
Country [1] 306457 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306991 0
Government body
Name [1] 306991 0
Auckland District Health Board (ADHB)
Address [1] 306991 0
Private Bag 92189
Auckland Mail Centre
Auckland 1142
Country [1] 306991 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306664 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 306664 0
Ethics committee country [1] 306664 0
New Zealand
Date submitted for ethics approval [1] 306664 0
03/08/2019
Approval date [1] 306664 0
18/05/2020
Ethics approval number [1] 306664 0
19/NTA/169

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104606 0
Dr Matthew Moore
Address 104606 0
School of Medicine
Faculty of Medical and Health Sciences
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
Country 104606 0
New Zealand
Phone 104606 0
+64 9 923 2899
Fax 104606 0
Email 104606 0
[email protected]
Contact person for public queries
Name 104607 0
Matthew Moore
Address 104607 0
School of Medicine
Faculty of Medical and Health Sciences
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
Country 104607 0
New Zealand
Phone 104607 0
+64 9 923 2899
Fax 104607 0
Email 104607 0
[email protected]
Contact person for scientific queries
Name 104608 0
Matthew Moore
Address 104608 0
School of Medicine
Faculty of Medical and Health Sciences
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
Country 104608 0
New Zealand
Phone 104608 0
+64 9 923 2899
Fax 104608 0
Email 104608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
EEG and EMG traces, with trial markers.
Participant primary diagnosis
Participant SCS electrode location
Participant handedness
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
We are experimenting with a new form of data sharing, approved by the HDEC, which gives more weight to the model of research as a collaboration between researchers and participants.

Data from some participants may be freely available, some may be available with the approval of an ethics board or third party, and some unavailable. The research team will execute the wishes of the participants.
Available for what types of analyses?
Any.
How or where can data be obtained?
Metadata will be uploaded to the University of Auckland data repository (https://auckland.figshare.com), University of Auckland staff will mediate data requests in accordance with participant wishes. Contact details will be provided with the metadata. The DOI has been reserved, and will be: 10.17608/k6.auckland.13082792


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8811Study protocol    380387-(Uploaded-13-10-2020-14-21-04)-Study-related document.pdf
8812Analytic code    Not available yet.
8815Other    Data management plan 380387-(Uploaded-10-11-2020-14-23-40)-Study-related document.pdf



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.