Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284694
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-14
Brief Title:
Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Treatment of Neuropathic Pain Following Spinal Cord Injury - a Repetitive Transcranial Magnetic Stimulation Approach
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Approximately 86000 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 Participants 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 20 Generalized Anxiety Disorder scale-7 GAD-7 Patient Health Questionnaire-9 PHQ-9 and previous medication and treatment questionnaires Participants 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 participants 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
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 Participants 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 20 Generalized Anxiety Disorder scale-7 GAD-7 Patient Health Questionnaire-9 PHQ-9 and previous medication and treatment questionnaires Participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None