🔄 CRITERIA UPDATE Added: Chronic period — SCI at C5–T10 level from 1 year post-injury
Rivne Regional Clinical Hospital · Clinical Research
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University of British Columbia
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Rivne Regional Clinical Hospital
Clinical Trial · NISCS

Non-Invasive Spinal Cord
Stimulation

A joint study by the University of British Columbia (Canada) and Rivne Regional Clinical Hospital investigates the effect of transcutaneous electrical stimulation on bladder, bowel, and sexual function in people with spinal cord injury.

Recruitment is open
📧 Email the coordinator 📞 +38 095 549 40 06 Eligibility criteria ↓
🗓️
Duration
~33 weeks
🔬
Sessions
58 visits
✅
Cost
Free of charge
🇨🇦
Partner
UBC · ICORD
📢
Criteria update

New eligibility group added

In addition to the subacute period (3–6 months post-SCI), participants with a chronic spinal cord injury (1+ year) at levels C5–T10 are now eligible. Both groups must have documented lower urinary tract dysfunction and AIS A or B classification.

About the study

What is tSCS and why does it matter?

Transcutaneous Spinal Cord Stimulation (tSCS) is a non-invasive technique that delivers low-level electrical impulses to the spinal cord through electrodes placed on the skin — no surgery, no implants.

The NISCS trial examines how tSCS affects bladder, bowel, sexual, cardiac, motor function, and muscle spasticity. The study also evaluates the overall impact on quality of life.

Participants are randomized into an active stimulation group (Group 1) or a sham therapy group (Group 2) for 8 weeks — 1.5 hours per session, 3 sessions per week — alongside conventional rehabilitation.

Research team
AK
Dr. Andrei Krassioukov
Professor, Division of Physical Medicine and Rehabilitation, UBC · Chair of the International Autonomic Standards Committee, ASIA/ISCoS
AB
Dr. Andrii Burachyk
Research team, Rivne Regional Clinical Hospital
Study protocol
58
Visits for assessment, therapy, and follow-up
~33
Weeks total study duration
16
Weeks of active stimulation (both groups)
3×
Sessions per week, 1.5 hours each
Eligibility

Who can participate?

Review the inclusion and exclusion criteria before contacting the coordinator.

✅

Inclusion criteria

  • ✓Resident of Ukraine with a valid healthcare agreement
  • ✓Age 19–65 at the time of informed consent
  • ✓Subacute period — 3–6 months post-SCI at level C5–T10
  • ✓Chronic period — SCI at level C5–T10 from 1 year post-injury NEW
  • ✓Documented lower urinary tract dysfunction (LUTD)
  • ✓Complete motor spinal cord injury — AIS A or B
  • ✓Ability to provide written informed consent
  • ✓Agreement to attend all scheduled visits and follow bowel/LUTD care procedures
  • ✓Agreement to refrain from starting new bowel or LUTD medications without notifying the principal investigator
  • ✓Persons of childbearing potential: negative pregnancy test before baseline; use of adequate contraception throughout the study and for at least 28 days after
🚫

Exclusion criteria

  • ✕Clinically significant depression with suicidal ideation (PHQ-9 > 20) or debilitating PTSD (PCL-5 > 31–33)
  • ✕Bladder augmentation surgery or prior bladder surgery
  • ✕Evidence of lower motor neuron injury (conus medullaris / cauda equina)
  • ✕Intradetrusor or intrasphincter onabotulinum toxin A injections within 9 months before the first visit
  • ✕Concomitant medications or treatments that may affect outcomes — at investigator's discretion
  • ✕Cognitive impairment, social/psychological issues, or comorbidities that would interfere with participation
  • ✕Serious acute conditions (stage 3/4 pressure ulcers, uncontrolled diabetes)
  • ✕Current or planned participation in another study that may affect primary endpoints

⚠️ Contraindications to tSCS

⚡ Cardiac pacemaker 🔩 Metal in spine/SC 💊 Baclofen pump 🔌 Neuromodulator
How to participate

Contact the coordinator

Interested in participating? Submit a short application — coordinator Roman Luchko will contact you within 1–2 business days to discuss details and schedule a screening visit.

Status: 🟢 recruitment is open.

👤
Coordinator
Roman Luchko
📧
📞
📍
Study location
Rivne Regional Clinical Hospital
39 Derazhnenska St., Klevan, Rivne Oblast, 35311, Ukraine
📋

Apply to participate

Fill out a short form — it takes 2–3 minutes. The coordinator will contact you personally.

🔒 Your data is shared exclusively with the study coordinator and used only for participation-related communication.
NISCS Clinical Trial

📋 Participation Application

After receiving your application, the coordinator will contact you within 1–2 business days.

📞 Call 📧 Email instead
Watch the video

Researchers about the NISCS trial

Prof. Andrei Krassioukov (UBC) and Dr. Andrii Burachyk (Rivne Regional Clinical Hospital) explain the significance of the study.

Prof. Andrei Krassioukov · UBC

«On daily basis one person in Ukraine sustained horrific spinal injury... We are excited to have this collaboration from the site of the Rivne regional hospital — the future National Spinal Injury Center.»

Dr. Andrii Burachyk · Rivne Regional Clinical Hospital

«We are pleased to announce the clinical trial of non-invasive spinal cord stimulation currently underway — the study is funded by the U.S. Department of Defense.»

▶ Watch on YouTube ↗
What participants receive

Your contribution to research

Participating in a clinical trial is not only scientifically valuable — it brings real personal benefits.

⚡
Free tSCS therapy
Up to 16 weeks of non-invasive spinal cord stimulation — a method not typically available outside clinical trials.
🏥
International expert team
Supervised by physicians, neurologists, urologists, physiotherapists, and biomedical engineers from UBC (Canada) and Rivne Regional Clinical Hospital.
📋
Full neurological assessment
Comprehensive evaluation of bladder, bowel, cardiovascular, and motor function throughout the entire study.
🔬
Impact on science
Your data will help develop new SCI treatment standards for thousands of people in Ukraine and worldwide.
💊
Conventional rehabilitation
Alongside stimulation, you receive a full rehabilitation programme from the hospital team.
🛡️
Safety & monitoring
The study is funded by the U.S. Department of Defense. All procedures are under continuous safety monitoring per international protocols.
Questions & Answers

Frequently asked questions

Still have questions? Contact the coordinator: niscs.rogvv@gmail.com

No. Transcutaneous (non-invasive) stimulation is delivered via electrodes placed on the skin — no surgery, no implants. Most participants describe the sensation as mild tingling or vibration. The procedure is safe and requires no anaesthesia.
The protocol involves 58 visits over ~33 weeks. The active stimulation phase requires 3 sessions per week, each lasting 1.5 hours. The schedule is agreed individually with the study coordinator.
Participation is voluntary. All study procedures are free of charge. For details on possible travel cost reimbursement, please contact coordinator Roman Luchko.
Submit an application or call the coordinator — even if you are unsure about eligibility. The coordinator will conduct a preliminary screening and advise whether you qualify, or whether new protocols are planned.
Yes. Participation is entirely voluntary. You have the right to withdraw your consent and discontinue participation at any time, without any consequences for your ongoing medical care.
All procedures are conducted at the Rivne Regional Clinical Hospital, 39 Derazhnenska St., Klevan, Rivne Oblast (35311), Ukraine — approximately 15 km from Rivne city. The schedule is arranged individually.
Rivne Regional Clinical Hospital
The study is conducted within an international partnership between University of British Columbia (ICORD, Canada) and Rivne Regional Clinical Hospital. More about the UBC research team: icord.org → Dr. Andrei Krassioukov