Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000746932
Ethics application status
Approved
Date submitted
26/05/2020
Date registered
20/07/2020
Date last updated
12/12/2022
Date data sharing statement initially provided
20/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of strong magnetic fields on the communication between brain and arm after spinal cord injury.
Scientific title
Safety and feasibility of low-intensity repetitive Transcranial Magnetic Stimulation ( rTMS) in human spinal cord injury: a translational approach.
Secondary ID [1] 301384 0
None
Universal Trial Number (UTN)
U1111-1252-6519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 317641 0
Condition category
Condition code
Injuries and Accidents 315722 315722 0 0
Other injuries and accidents
Neurological 316013 316013 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will use rTMS at a frequency of 10HZ for up to 1800 pulses. The rTMS can either have a low intensity, a per-threshold intensity or can be a sham rTMS.
TMS will be delivered by a researcher experienced with this technique.
rTMS will be delivered on an individual basis. Participants will receive 6 sessions of rTMS separated by at least 1 week (twice HI, LI and sham). After and before one session participants will undergo behavioural testing, after the second session participants will undergo a neurophysiological assessment. Session order is randomised. Before the start of the study participants will come in for a screening visit.
Experiments will be conducted at Edith Cowan University in Joondalup, WA.
Intervention code [1] 317689 0
Rehabilitation
Intervention code [2] 317902 0
Treatment: Devices
Comparator / control treatment
The study includes a control condition, that is sham stimulation. All participants receive all treatment but sham treatment will be used a control.
Control group
Placebo

Outcomes
Primary outcome [1] 323931 0
Resting motor threshold (cortical excitability), assessed via Transcranial Magnetic Stimulation and this response to TMS is measured EMG at the muscle.
Timepoint [1] 323931 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Primary outcome [2] 324049 0
MEP amplitude at 120% RMT, assessed with Transcranial Magnetic Stimulation. This response to TMS is measured with EMG at the muscle.
Timepoint [2] 324049 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Primary outcome [3] 324050 0
M-waves, assessed through peripheral nerve stimulation and the recorded EMG response in response to this stimulation.
Timepoint [3] 324050 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [1] 383368 0
Movement kinematics evaluated with a KinArm robot.
Timepoint [1] 383368 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [2] 383623 0
Finger dexterity assessed with the Nine-Hole Peg Test (9-HPT).
Timepoint [2] 383623 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [3] 383624 0
Sensory perception threshold, assessed with monofilaments.
Timepoint [3] 383624 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [4] 383625 0
Neurophysiological assessment of the sensory system, assessed with somatosensory evoked potentials (SSEPs). That is the EEG response to peripheral nerve stimulation.
Timepoint [4] 383625 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [5] 383626 0
The amount of inhibition in the brain, assessed via Transcranial Magnetic Stimulation and this response to TMS is measured with EMG at the muscle.
Timepoint [5] 383626 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [6] 383627 0
The amount of inhibition in the brain, assessed via Transcranial Magnetic Stimulation during a voluntary contraction and this response to TMS is measured with EMG at the muscle.
Timepoint [6] 383627 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).
Secondary outcome [7] 383628 0
Amount of voluntary activation of a muscle, assessed with maximum voluntary EMG in one of the arm muscles (FCR, ECR, biceps or triceps) by making an maximum isometric contraction.
Timepoint [7] 383628 0
Once before and after each rTMS condition (sham, low intensity and peri-threshold intensity).

Eligibility
Key inclusion criteria
Minimum 18 years of age
Chronic stage (>1 year post-injury)
Cervical injury level
Traumatic lesion
Residual upper limb motor deficit with muscle weakness
No joint-related limitation of passive range of movement of the elbow
Presence of MEPs in the arm (assessed during the first visit)
Able to read and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of trauma-related brain injury
Pre-injury neurological condition affecting motor or sensory systems
Contraindications for TMS
Medically unstable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study is funded as a feasibility study and there is no data available around the effectiveness of LI-rTMS in people who suffered a spinal cord injury. Therefore, no power calculation was made. However, a previous feasibility and safety study found significant improvements in clinical outcomes after applying HF-rTMS in 4 subjects.
The data will be analysed using parametric testing, once confirmed that the data are normally distributed. Post hoc multiple pairwise comparisons will be made with Bonferroni t-test where appropriate.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2020
Actual
8/09/2020
Date of last participant enrolment
Anticipated
1/06/2022
Actual
23/06/2021
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305824 0
Other Collaborative groups
Name [1] 305824 0
NeuroTrauma Research Program
Country [1] 305824 0
Australia
Primary sponsor type
Individual
Name
Dr. Onno van der Groen
Address
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 306268 0
None
Name [1] 306268 0
Address [1] 306268 0
Country [1] 306268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306092 0
ECU Human Research Ethics Committee
Ethics committee address [1] 306092 0
Ethics committee country [1] 306092 0
Australia
Date submitted for ethics approval [1] 306092 0
27/02/2020
Approval date [1] 306092 0
22/05/2020
Ethics approval number [1] 306092 0
2019-00490-VANDERGROEN

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

Contacts
Principal investigator
Name 102674 0
Dr Onno van der Groen
Address 102674 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 102674 0
Australia
Phone 102674 0
+61 8 6304 3644
Fax 102674 0
Email 102674 0
o.vandergroen@ecu.edu.au
Contact person for public queries
Name 102675 0
Onno van der Groen
Address 102675 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 102675 0
Australia
Phone 102675 0
+61 8 6304 3644
Fax 102675 0
Email 102675 0
o.vandergroen@ecu.edu.au
Contact person for scientific queries
Name 102676 0
Onno van der Groen
Address 102676 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 102676 0
Australia
Phone 102676 0
+61 8 6304 3644
Fax 102676 0
Email 102676 0
o.vandergroen@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will be discussed with the research team in due course.


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.