Spinal Cord Injury CervicalNCT05362422
PAS for Post-SCI Neuropathic Pain
A study testing long-term paired associative stimulation in people with Spinal Cord Injury Cervical and Neuropathic Pain, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Neuropathic Pain
- What is being tested?
- long-term paired associative stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFinland
- Study dates
- 22 Apr 2022to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- incomplete cervical spinal cord injury
- time from injury at least 1.5 years
- chronic SCI- induced neuropathic pain in the upper limb
Who cannot join
- Diagnosed brain damage, visible in MRI or CT.
- No activity in hands/fingers and no MEPs recorded from distal hand muscles.
- Epilepsy
- Metal inclusion in the head area
- High intracranial pressure
- Pacemaker
Show all 17Show fewer
- Implanted hearing device
- Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
- Previous head or spinal cord injury affecting the motor performance of upper extremities.
- Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
- Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
- Acute severe infection.
- Contraindications for MRI.
- Current severe psychiatric diseases.
- Current chronic drug and/or alcohol abuse.
- Pregnancy.
- Pressure ulcer affecting the subject's capability to undergo the procedure safely
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.
- Conditions
- Spinal Cord Injury Cervical, Neuropathic Pain
- Being tested
- long-term paired associative stimulation, sham long-term paired associative stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-term paired associative stimulationDevice
Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
sham long-term paired associative stimulationDevice
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| PAS | Experimental | Not described Receives: Device: long-term paired associative stimulation |
| SHAM | Sham comparator | Not described Receives: Device: sham long-term paired associative stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
0-10 scale, 0 - no pain, 10 - worst possible pain.
Measured: Change from baseline at 1 day after the intervention
Brief Pain Inventory
0-10 scale, 0 - no pain, 10 - worst possible pain.
Measured: Change from baseline at 8 weeks after the intervention
Numeric Rating Scale
0-10 scale, 0 - no pain, 10 - worst possible pain.
Measured: Change from baseline at 1 day after the intervention
Numeric Rating Scale
0-10 scale, 0 - no pain, 10 - worst possible pain.
Measured: Change from baseline at 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start22 Apr 2022
- Primary completion22 May 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Shulga, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362422
- Sponsor's protocol ID
- TYH2020244
- Status last verified
- Sep 2023
- First submitted
- 22 Apr 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.
PubMed 33738876Vaalto S, Nyman AL, Shulga A. Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. Scand J Pain. 2021 May 21;21(4):831-838. doi: 10.1515/sjpain-2021-0012. Print 2021 Oct 26.
PubMed 34019752Holopainen K, Pohjonen M, Kirveskari E, Vaalto S, Makela JP, Arokoski J, Shulga A. Paired associative stimulation with a high-intensity cortical component and a high-frequency peripheral component in treatment of neuropathic pain after incomplete spinal cord injury - a pilot trial. Spinal Cord Ser Cases. 2026 Mar 4;12(1):3. doi: 10.1038/s41394-026-00729-1.
PubMed 41776169
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05362422
- Acronym / sponsor ID
- TYH2020244
- Conditions
- Spinal Cord Injury Cervical, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAS | Experimental | Device: long-term paired associative stimulation |
| SHAM | Sham comparator | Device: sham long-term paired associative stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- incomplete cervical spinal cord injury
- time from injury at least 1.5 years
- chronic SCI- induced neuropathic pain in the upper limb
Key exclusion criteria (17 listed)
- Diagnosed brain damage, visible in MRI or CT.
- No activity in hands/fingers and no MEPs recorded from distal hand muscles.
- Epilepsy
- Metal inclusion in the head area
- High intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long-term paired associative stimulationPaired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)). | Device | PAS |
| sham long-term paired associative stimulationSham transcranial magnetic stimulation and sham peripheral nerve stimulation. | Device | SHAM |
Primary outcome
Brief Pain Inventory
Time frame: Change from baseline at 1 day after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
Brief Pain Inventory
Time frame: Change from baseline at 8 weeks after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
Numeric Rating Scale
Time frame: Change from baseline at 1 day after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
Numeric Rating Scale
Time frame: Change from baseline at 8 weeks after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 33738876Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.
- Background: PubMed 34019752Vaalto S, Nyman AL, Shulga A. Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. Scand J Pain. 2021 May 21;21(4):831-838. doi: 10.1515/sjpain-2021-0012. Print 2021 Oct 26.
- Derived from this study: PubMed 41776169Holopainen K, Pohjonen M, Kirveskari E, Vaalto S, Makela JP, Arokoski J, Shulga A. Paired associative stimulation with a high-intensity cortical component and a high-frequency peripheral component in treatment of neuropathic pain after incomplete spinal cord injury - a pilot trial. Spinal Cord Ser Cases. 2026 Mar 4;12(1):3. doi: 10.1038/s41394-026-00729-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long-term paired associative stimulation in people with Spinal Cord Injury Cervical and Neuropathic Pain, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: Change from baseline at 1 day after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.