Neuropathic PainNCT06284694
Treatment of Neuropathic Pain Following Spinal Cord Injury - a RTMS Approach
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Neuropathic Pain, run by University of Calgary at 1 site in Canada.
Trial summary
This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 30 Jun 2025
- 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
- Physician-diagnosed spinal cord injury
- Neuropathic pain for at least 3-months, as diagnosed by a physician
- Pain not attributable to any other conditions
- Aged 18-75 years
- Can complete wheelchair transfers independently
Who cannot join
- Prior history of transcranial magnetic stimulation (TMS) therapy
- Any TMS-related contraindications, for example: pacemaker, metallic implant, other medical conditions such as structural brain disease, previous seizure, psychiatric disorders (excluding depression and anxiety), suicide attempt in the past 6 months, liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and current pregnancy or the desire to become pregnant in the next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Neuropathic Pain Following Spinal Cord Injury - a Repetitive Transcranial Magnetic Stimulation Approach
This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI).
Read the detailed description
Approximately 86,000 Canadians live with a spinal cord injury (SCI). Individuals with a SCI experience varying levels of deficits in motor and sensory function and sometimes paralysis. SCI can result in permanent impairments both physical and psychological, as the loss of body function greatly impacts quality of life. Neuropathic pain (NP) is a common complication following SCI. Damage or dysfunction to the nervous system after SCI commonly leads to secondary injury or disease in the somatosensory system, which may contribute to NP. This debilitating complication can impede many factors including physical function, rehabilitation, sleep, and return to work.
Treatment modalities for NP aim to reduce pain and improve function and quality of life. Pharmacological interventions are considered first-line therapy for NP management, though there remains limited evidence to support the efficacy of this treatment modality. Pharmacologic therapies may also include negative side effects. Additionally, clinical guidelines for NP management recommend including non-pharmacologic strategies. Therefore, an interdisciplinary strategy may be required to effectively mitigate NP after SCI. Evidence of neuromodulation techniques to improve various pain conditions is well established, and reductions in pain may be related to the modified brain activity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation intervention with a low risk of adverse effects. Preliminary studies investigating rTMS for NP after SCI have shown a therapeutic effect after treatment whereby quality of life and pain improved in this population.
RESEARCH QUESTION AND OBJECTIVES
This study aims to determine the clinical feasibility of a rTMS protocol to improve pain symptomology in adults with NP following SCI. Additionally, this study will contribute to the limited body of evidence for the efficacy of this treatment modality in this population.
The primary objective is to determine symptomatic changes in pain profile and treatment response using the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, a valid and reliably tested instrument, and the PROMIS Scale Neuropathic Pain Quality 5a questionnaire.
Secondary objectives include assessing quality of life (QLI-SCI), depression (PHQ-9), anxiety (GAD-7), disability (WHODAS), and pain catastrophizing (PCS).
METHODS
Clinical Assessments: Demographic information, including age, sex, gender, and past medical history will be collected prior to participation. Participant's neurological level of impairment will be determined by a treating physician, allied health professional, or research study physician. The initial assessment will include answering questionnaires: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, PROMIS Scale Neuropathic Pain Quality 5a questionnaire, Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS), World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Generalized Anxiety Disorder scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and previous medication and treatment questionnaires. Participant's current medication usage will be monitored during the study and rTMS tolerability will be assessed immediately following each treatment session. Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment, at 1 and 3 months after their last rTMS treatment.
TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with an inter-train interval of 45-seconds. Treatment intensity will be applied at 100-120% of the participant's resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex. Electromyography (EMG) electrodes will be placed on the contralateral abductor pollicis brevis (APB) muscle to determine the motor evoked potential peak-to-peak amplitude, requiring 50 microvolts amplitude in 5 of 10 consecutive stimulations. The rTMS treatment will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36). Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.
- Conditions
- Neuropathic Pain
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Spinal Cord Injury
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
See experimental arm description
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a
Neuropathic pain will be assessed using the PROMIS Scale Neuropathic Pain Quality 5a questionnaire. This tool assesses 5 descriptors of neuropathic pain quality. Participants are asked to rate their pain quality from 1(not at all) to 5 (very much) using a recall period of the past 7 days.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Secondary outcomes (5)
Quality of Life Index Spinal Cord Injury version (QLI-SCI)
Quality of life and satisfaction with aspects of quality of life will be assessed using the QLI-SCI instrument. This questionnaire focuses on the categories of health and functioning, social and economic, psychological/spiritual, and family.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain Catastrophizing Scale (PCS)
Pain experience will be assessed using the PCS. Participants are asked to rate how much they agree with the listed thoughts and feelings they may have when experiencing pain from 0 (not at all) to 4 (all the time).
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
World Health Organization Disability Assessment Schedule (WHODAS) 2.0
Health and disability will be assessed using the WHODAS 2.0 instrument. Participants will be asked to rate the amount of difficulty that have had completing activities over the past 30 days using the scale none to extreme or cannot do.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Generalized Anxiety Disorder scale-7 (GAD-7)
Anxiety will be assessed using the GAD-7 tool. Participants will rate the frequency of anxious feelings from 0 (not at all) to 3 (nearly every day), thinking back over the past 2 weeks. Higher scores will indicate a greater severity of anxiety symptoms.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Patient Health Questionnaire-9 (PHQ-9)
Depression will be assessed using the PHQ-9 tool. Participants will rate the frequency of depressive thoughts and/or feelings experienced over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher scores will indicate a greater severity of depressive symptoms.
Measured: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive active rTMS treatment.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantel T Debert, MD MSc FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284694
- Sponsor's protocol ID
- REB23-0120
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burke D, Fullen BM, Stokes D, Lennon O. Neuropathic pain prevalence following spinal cord injury: A systematic review and meta-analysis. Eur J Pain. 2017 Jan;21(1):29-44. doi: 10.1002/ejp.905. Epub 2016 Jun 24.
PubMed 27341614Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16.
PubMed 29249383Almeida C, Monteiro-Soares M, Fernandes A. Should Non-Pharmacological and Non-Surgical Interventions be Used to Manage Neuropathic Pain in Adults With Spinal Cord Injury? - A Systematic Review. J Pain. 2022 Sep;23(9):1510-1529. doi: 10.1016/j.jpain.2022.03.239. Epub 2022 Apr 10.
PubMed 35417793Shen Z, Li Z, Ke J, He C, Liu Z, Zhang D, Zhang Z, Li A, Yang S, Li X, Li R, Zhao K, Ruan Q, Du H, Guo L, Yin F. Effect of non-invasive brain stimulation on neuropathic pain following spinal cord injury: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Aug 21;99(34):e21507. doi: 10.1097/MD.0000000000021507.
PubMed 32846761Saleh C, Ilia TS, Jaszczuk P, Hund-Georgiadis M, Walter A. Is transcranial magnetic stimulation as treatment for neuropathic pain in patients with spinal cord injury efficient? A systematic review. Neurol Sci. 2022 May;43(5):3007-3018. doi: 10.1007/s10072-022-05978-0. Epub 2022 Mar 3.
PubMed 35239053Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
PubMed 18003941Sun X, Long H, Zhao C, Duan Q, Zhu H, Chen C, Sun W, Ju F, Sun X, Zhao Y, Xue B, Tian F, Mou X, Yuan H. Analgesia-enhancing effects of repetitive transcranial magnetic stimulation on neuropathic pain after spinal cord injury:An fNIRS study. Restor Neurol Neurosci. 2019;37(5):497-507. doi: 10.3233/RNN-190934.
PubMed 31381538Seminowicz DA, Moayedi M. The Dorsolateral Prefrontal Cortex in Acute and Chronic Pain. J Pain. 2017 Sep;18(9):1027-1035. doi: 10.1016/j.jpain.2017.03.008. Epub 2017 Apr 8.
PubMed 28400293Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.
PubMed 15546593
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Neuropathic Pain Following Spinal Cord Injury - a Repetitive Transcranial Magnetic Stimulation Approach
- ClinicalTrials.gov ID
- NCT06284694
- Acronym / sponsor ID
- REB23-0120
- Conditions
- Neuropathic Pain
- Keywords
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Feb 2024 (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.
This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI).
Detailed description
Approximately 86,000 Canadians live with a spinal cord injury (SCI). Individuals with a SCI experience varying levels of deficits in motor and sensory function and sometimes paralysis. SCI can result in permanent impairments both physical and psychological, as the loss of body function greatly impacts quality of life. Neuropathic pain (NP) is a common complication following SCI. Damage or dysfunction to the nervous system after SCI commonly leads to secondary injury or disease in the somatosensory system, which may contribute to NP. This debilitating complication can impede many factors including physical function, rehabilitation, sleep, and return to work.
Treatment modalities for NP aim to reduce pain and improve function and quality of life. Pharmacological interventions are considered first-line therapy for NP management, though there remains limited evidence to support the efficacy of this treatment modality. Pharmacologic therapies may also include negative side effects. Additionally, clinical guidelines for NP management recommend including non-pharmacologic strategies. Therefore, an interdisciplinary strategy may be required to effectively mitigate NP after SCI. Evidence of neuromodulation techniques to improve various pain conditions is well established, and reductions in pain may be related to the modified brain activity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation intervention with a low risk of adverse effects. Preliminary studies investigating rTMS for NP after SCI have shown a therapeutic effect after treatment whereby quality of life and pain improved in this population.
RESEARCH QUESTION AND OBJECTIVES
This study aims to determine the clinical feasibility of a rTMS protocol to improve pain symptomology in adults with NP following SCI. Additionally, this study will contribute to the limited body of evidence for the efficacy of this treatment modality in this population.
The primary objective is to determine symptomatic changes in pain profile and treatment response using the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, a valid and reliably tested instrument, and the PROMIS Scale Neuropathic Pain Quality 5a questionnaire.
Secondary objectives include assessing quality of life (QLI-SCI), depression (PHQ-9), anxiety (GAD-7), disability (WHODAS), and pain catastrophizing (PCS).
METHODS
Clinical Assessments: Demographic information, including age, sex, gender, and past medical history will be collected prior to participation. Participant's neurological level of impairment will be determined by a treating physician, allied health professional, or research study physician. The initial assessment will include answering questionnaires: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, PROMIS Scale Neuropathic Pain Quality 5a questionnaire, Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS), World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Generalized Anxiety Disorder scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and previous medication and treatment questionnaires. Participant's current medication usage will be monitored during the study and rTMS tolerability will be assessed immediately following each treatment session. Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment, at 1 and 3 months after their last rTMS treatment.
TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with an inter-train interval of 45-seconds. Treatment intensity will be applied at 100-120% of the participant's resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex. Electromyography (EMG) electrodes will be placed on the contralateral abductor pollicis brevis (APB) muscle to determine the motor evoked potential peak-to-peak amplitude, requiring 50 microvolts amplitude in 5 of 10 consecutive stimulations. The rTMS treatment will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36). Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive active rTMS treatment.
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physician-diagnosed spinal cord injury
- Neuropathic pain for at least 3-months, as diagnosed by a physician
- Pain not attributable to any other conditions
- Aged 18-75 years
- Can complete wheelchair transfers independently
Key exclusion criteria (2 listed)
- Prior history of transcranial magnetic stimulation (TMS) therapy
- Any TMS-related contraindications, for example: pacemaker, metallic implant, other medical conditions such as structural brain disease, previous seizure, psychiatric disorders (excluding depression and anxiety), suicide attempt in the past 6 months, liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and current pregnancy or the desire to become pregnant in the next 6 months.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)See experimental arm description | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) |
Primary outcome
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool.
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Neuropathic pain will be assessed using the PROMIS Scale Neuropathic Pain Quality 5a questionnaire. This tool assesses 5 descriptors of neuropathic pain quality. Participants are asked to rate their pain quality from 1(not at all) to 5 (very much) using a recall period of the past 7 days.
5 secondary outcomes
Quality of Life Index Spinal Cord Injury version (QLI-SCI)
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain Catastrophizing Scale (PCS)
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
World Health Organization Disability Assessment Schedule (WHODAS) 2.0
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Generalized Anxiety Disorder scale-7 (GAD-7)
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 27341614Burke D, Fullen BM, Stokes D, Lennon O. Neuropathic pain prevalence following spinal cord injury: A systematic review and meta-analysis. Eur J Pain. 2017 Jan;21(1):29-44. doi: 10.1002/ejp.905. Epub 2016 Jun 24.
- Background: PubMed 29249383Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16.
- Background: PubMed 35417793Almeida C, Monteiro-Soares M, Fernandes A. Should Non-Pharmacological and Non-Surgical Interventions be Used to Manage Neuropathic Pain in Adults With Spinal Cord Injury? - A Systematic Review. J Pain. 2022 Sep;23(9):1510-1529. doi: 10.1016/j.jpain.2022.03.239. Epub 2022 Apr 10.
- Background: PubMed 32846761Shen Z, Li Z, Ke J, He C, Liu Z, Zhang D, Zhang Z, Li A, Yang S, Li X, Li R, Zhao K, Ruan Q, Du H, Guo L, Yin F. Effect of non-invasive brain stimulation on neuropathic pain following spinal cord injury: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Aug 21;99(34):e21507. doi: 10.1097/MD.0000000000021507.
- Background: PubMed 35239053Saleh C, Ilia TS, Jaszczuk P, Hund-Georgiadis M, Walter A. Is transcranial magnetic stimulation as treatment for neuropathic pain in patients with spinal cord injury efficient? A systematic review. Neurol Sci. 2022 May;43(5):3007-3018. doi: 10.1007/s10072-022-05978-0. Epub 2022 Mar 3.
- Background: PubMed 18003941Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
- Background: PubMed 31381538Sun X, Long H, Zhao C, Duan Q, Zhu H, Chen C, Sun W, Ju F, Sun X, Zhao Y, Xue B, Tian F, Mou X, Yuan H. Analgesia-enhancing effects of repetitive transcranial magnetic stimulation on neuropathic pain after spinal cord injury:An fNIRS study. Restor Neurol Neurosci. 2019;37(5):497-507. doi: 10.3233/RNN-190934.
- Background: PubMed 28400293Seminowicz DA, Moayedi M. The Dorsolateral Prefrontal Cortex in Acute and Chronic Pain. J Pain. 2017 Sep;18(9):1027-1035. doi: 10.1016/j.jpain.2017.03.008. Epub 2017 Apr 8.
- Background: PubMed 15546593Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.
- Individual participant dataSharing planned: No
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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.
Chantel T Debert, MD MSc FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Neuropathic Pain, run by University of Calgary at 1 site in Canada.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Dec 2024. 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 Canada. 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. 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?
Results are not available in the source record.
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?
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version (time frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.). The study lists 2 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 NCT06284694, which also lists 9 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 18 Dec 2024.