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Trial registered on ANZCTR


Registration number
ACTRN12624000010594
Ethics application status
Approved
Date submitted
14/10/2023
Date registered
10/01/2024
Date last updated
3/11/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Noninvasive vagal nerve stimulation for abdominal symptoms in people with spinal cord injury
Scientific title
Noninvasive transcutaneous vagal nerve stimulation for abdominal symptoms in people with spinal cord injury
Secondary ID [1] 309353 0
Nil known
Universal Trial Number (UTN)
U1111-1299-0557
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal pain
 329560 0
spinal cord injury 332005 0
Condition category
Condition code
Oral and Gastrointestinal 326489 326489 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 328739 328739 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 328740 328740 0 0
Other physical medicine / rehabilitation
Neurological 328741 328741 0 0
Other neurological disorders
Injuries and Accidents 328742 328742 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcutaneous vagal nerve stimulation delivered by a hand-held device around the neck
-gammaCore(Transcutaneous VNS device) is a size of the card deck and is battery operated. It produces an electrical signal that consists of five 5000 Hz pulses. This pulse is repeated at a rate of 25 Hz. The waveform produced by this device is approximately sign wave.
-Initial stimulation will be delivered by nursing staff/doctor involved in study.
-Participants will deliver 2 minutes of stimulation on each side of the neck or scapula (total 4 minutes) twice a day (total 8 minutes).
-Participants will complete 4 weeks of stimulation on each site with 2 weeks wash-out period.
-Participants are to complete the treatment diary to record the stimulations delivered


Visit schedules
-The participant will complete baseline questionnaire prior to the first visit : This will assess participant’s medical history including nature of spinal cord injury, bowel function, picture map of abdominal pain, character of the pain, non-abdominal pain, quality of life questions, hospital anxiety and depression questionnaire and Rome questionnaire for disorders of gut-brain interaction.
-There will be 2 weeks lead-in period before the first visit.
-During the first visit : The participant will complete ECG and routine observations. These will be completed by either nurses/doctors involved in clinical trial. They may also receive abdominal x-ray and abdominal ultrasound. X-ray will be done at hospital radiology department. Ultrasound may be done at bed side by the doctor involved in this study.
-After this, the participant will undergo the first stimulation. First stimulation will be same in duration as routine as described above. Depending on the randomisation, stimulation will be at neck of scapula.
- If the first stimulation is successful, a participant (or carer) will be educated about how to use the VNS device and given a device to take home. Education will be done by the nurse/doctor involved in this clinical trial and will be approximately 15-30 minutes
-The participant will continue to deliver stimulation as per above schedule and will be asked to keep the diary for 4 weeks.
-At the end of 4 weeks, participant will have another visit to check on progress and ECG.
-The participant will be instructed to stimulate alternate sites for 4 weeks after 2 weeks wash-out period.
-On week 10, the participant will have end of treatment visit and ECG.

-The participant will complete the ‘progress questionnaire’ at week -2, 0, 4, 6 and 10. The progress questionnaire consists of questions addressing abdominal pain location (using a diagram), severity of abdominal pain, number of bowel motions, quality of life questions and hospital anxiety and depression score.
- Overall treatment duration will be 10 weeks. (4 weeks of each stimulation site + 2 weeks wash-out period)

The protocol was changed prior to the commencement of recruitment.(2024 Sep)
Intervention code [1] 327188 0
Treatment: Devices
Comparator / control treatment
No control group but two treatment sites will be compared. This is a proof-of-concept pilot study.
Control group
Active

Outcomes
Primary outcome [1] 334332 0
Pain scale - Ten point visual analogue scale
Timepoint [1] 334332 0
Assessed at week -2. 0, 4,6 and 10. Ten point visual analogue was designed based from international spinal cord injury pain basic data set/ bowel function data set.
Primary outcome [2] 336552 0
Abdominal pain map - Participant marks locations of the pain on diagram of abdomen/back
Timepoint [2] 336552 0
Assessed at week -2. 0, 4,6 and 10. This online interactive abdominal pain map was developed specifically for this study.
Secondary outcome [1] 428794 0
Autonomic dysreflexia
Timepoint [1] 428794 0
Patients will be asked if they had autonomic dysreflexia event at week -2. 0, 4,6 and 10.
No specific pre-validated questionnaire was used.

The timing of participants being asked about autonomic dysreflexia was changed prior to the commencement of recruitment to align with the modified outcome measurement timing (2024 Sep).
Secondary outcome [2] 428795 0
Quality of life using ten point visual analogue scale.
Timepoint [2] 428795 0
Assessed using at week -2. 0, 4,6 and 10.. Ten point visual analogue was designed based from international spinal cord injury pain basic data set/ bowel function data set.

Eligibility
Key inclusion criteria
Patients with spinal cord injury for at least 12 months
Currently experiencing abdominal symptoms, including abdominal pain/discomfort
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to complete questionnaires – whether due to impaired cognition or language barrier
Unable to deliver vagal nerve stimulation by him/herself OR does not have someone else who can deliver the VNS
Unable to attend required face-to-face visits
Any other implant device that may interfere with vagal nerve stimulation
Underlying significant cardiac abnormality, especially cardiac arrhythmia
(Relative contraindication) History of recurrent or severe autonomic dysreflexia

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24442 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40023 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 313553 0
Hospital
Name [1] 313553 0
Royal North Shore Hospital
Country [1] 313553 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 317035 0
None
Name [1] 317035 0
Address [1] 317035 0
Country [1] 317035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312734 0
The Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)
Ethics committee address [1] 312734 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065??
Ethics committee country [1] 312734 0
Australia
Date submitted for ethics approval [1] 312734 0
Approval date [1] 312734 0
21/07/2023
Ethics approval number [1] 312734 0
2023/ETH00832 and 2023/STE01288

Summary
Brief summary
This pilot study will examine the efficacy of transcutaneous (non-invasive) vagal nerve stimulation in people with spinal cord injury. Many people with spinal cord injury suffer from abdominal pain and gastrointestinal symptoms that do not respond to treatment target usual pain receptors. It has been postulated that these symptoms are mediated by the vagus nerve. Modulating the vagus nerve by transcutaneous stimulation may provide relief from these symptoms. Efficacy will be examined by patient-reported pain scores, pain maps, as gastrointestinal motility study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125714 0
Prof Allison Malcolm
Address 125714 0
Level 4 Gastroenterology Unit Royal North Shore Hospital Reserve Rd St Leonards NSW 2065
Country 125714 0
Australia
Phone 125714 0
+61 2 9462 9640
Fax 125714 0
Email 125714 0
[email protected]
Contact person for public queries
Name 125715 0
Calvin Park
Address 125715 0
Level 4 Gastroenterology Unit Royal North Shore Hospital Reserve Rd St Leonards NSW 2065
Country 125715 0
Australia
Phone 125715 0
+61 2 9462 2460
Fax 125715 0
Email 125715 0
[email protected]
Contact person for scientific queries
Name 125716 0
Allison Malcolm
Address 125716 0
Level 4 Gastroenterology Unit Royal North Shore Hospital Reserve Rd St Leonards NSW 2065
Country 125716 0
Australia
Phone 125716 0
+61 2 9462 9640
Fax 125716 0
Email 125716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.