Spinal Cord InjuriesNCT05226676
Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
A study testing Transcranial Magnetic Stimulation in people with Spinal Cord Injuries and Neuralgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuralgia, Chronic Pain
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord.
- cervical lesion.
- CNP in the upper extremity.
- pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the NPS both screening (baseline) and randomization (pre-evaluation).both screening (baseline) and randomization (pre-evaluation).
- stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial.
- complete or incomplete lesion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. There is a critical need to develop a new generation of therapies. Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. However there is not enough evidence of what are the long lasting effects of the different protocols. In this study, 30 SCI subjects with CNP in their hands will participate in the study. The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rTMS) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.This will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive TMS protocol (20Hz). The protocol will be done daily for two weeks. Clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.
- Conditions
- Spinal Cord Injuries, Neuralgia, Chronic Pain
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Spinal Cord Injuries, Neuropathic, Chronic Pain, Transcranial Magnetic Stimulation, Neural Plasticity, Pain
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows the brain excitability to change based on Faraday's Law of Electromagnetic induction . Since the presentation of the CNP is usually bilateral, the coil will be targeting the dominant hand abductor pollicis brevis (APB) muscle. If the pain is more intense in one of the arms, that arm will be targeted. This protocol was developed in accordance with the guidelines for the safe use of rTMS.
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS group | Experimental | Repetitive TMS at 20Hz frequency over the M1 will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). The rTMS will be applied through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. This protocol was developed in accordance with the guidelines for the safe use of rTMS. Receives: Device: Transcranial Magnetic Stimulation |
| Sham group | Sham comparator | Sham stimulation will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). For the sham stimulation a sham coil will be used. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Scale (NPS)
This scale was developed to assess both the quantitative and qualitative qualities of NP. It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total scale from 0-10, with higher score indicating more pain.
Measured: 6 weeks
Secondary outcomes (14)
Numeric Rating Scale (NRS)
NRS to measure pain sensation, total score from 0-10, higher score indicates more intense pain.
Measured: 6 weeks
Short-Form McGill Pain Questionnaire. (SF-MPQ)
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or, 3 = severe. The SF-MPQ can be scored in several ways: a) number of words/descriptors chosen by the patient. Total scale from 0 to 45, with higher score indicating higher the pain experienced.
Measured: 6 weeks
Present Pain Intensity (PPI) index
In the PPI index the adjectives/descriptors are ranked according to increasing intensity so each descriptor can be assigned a higher score: 0= no pain, 1=mild, 2=discomforting, 3= distressing, 4= horrible, 5= excruciating. Full range from 0 to 75, with higher score indicating higher intensity pain experienced.
Measured: 6 weeks
Visual Analogue Scale (VAS)
The Visual Analogue Scale is the pain rating scale. Full scale from 0 to 10, with higher score indicating more pain.
Measured: 6 weeks
The American Spinal Injury Association Impairment Scale (ASIA scale)
Upper extremity motor score (UEMS) will test the clinical motor strength from 0 to 5 of each key muscle using the ASIA scale in both arms. This sum score will range from 0 (paralyzed) to 25 (normal) in each limb (total of 50 bilaterally). Higher score indicates better health outcomes
Measured: 6 weeks
Spinal cord independence measure (SCIM III)
Spinal cord independence measure (SCIM III) measures the ability of patients with SCI to perform everyday tasks. SCIM is used for quantitative functional outcome assessment following interventions designed to promote recovery from spinal cord injury and to increase functional achievement; it covers 19 tasks in 16 categories, with a total score range 0-100; all activities of daily living, grouped into four areas of function (subscales): Self-Care (scored 0-20), Respiration and Sphincter Management (0-40), Mobility in Room and Toilet (0-10), and Mobility Indoors and Outdoors (0-30). Higher score indicates better health outcomes.
Measured: 6 weeks
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) will measure changes in spasticity in the upper limbs after the stimulation period. For each upper limb, full Score range from 0 to 4, where lower. scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: 6 weeks
Beck Depression Inventory (BDI)
This questionnaire is a 21-item, selfreport rating inventory that measures characteristic attitudes and symptoms of depression. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Measured: 6 weeks
Patient's Global Impression of Change (PGIC)
Full scale from 0-7, higher score indicates better health outcomes. he patients will answer the following question: "Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?"
Measured: 6 weeks
Resting Motor Threshold (RMT)
Using transcranial magnetic stimulation (TMS) and electromyography (EMG) to measure RMT. Motor threshold is considered to reflect membrane-related intrinsic neuronal excitability.
Measured: 6 weeks
Recruitment curve (RC)
Using transcranial magnetic stimulation (TMS) and electromyography (EMG) to measure RC. The median amplitude at a given intensity is thought to represent trans-synaptic excitability of the corticospinal pathways.
Measured: 6 weeks
Short intracortical inhibition (SICI)
Using transcranial magnetic stimulation (TMS) and electromyography (EMG) to measure SICI. A single pulse TMS stimulus can be inhibited if preceded by a subthreshold conditioning stimulus 3 milliseconds apart. The SICI determines if changes in corticospinal output are related to altered intracortical excitability.
Measured: 6 weeks
Silent period (SP):
Using transcranial magnetic stimulation (TMS) and electromyography (EMG) to measure SP. During muscle contraction, the MEP is followed by a period of silent EMG activity. Changes in intracortical inhibition are reflected in altered SP duration.
Measured: 6 weeks
Sensory threshold (ST):
Using a constant current electrical stimulator (Digitimer), sensory threshold can be quantified. It is defined as the weakest stimulus that can be detected.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The PI left the institution and the study couldn't be transfer to a new PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded sham controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Del Mar Cortes, Icahn School of Medicine at Mount Sinai
- Investigators
- Mar Cortes, M.D., Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226676
- Sponsor's protocol ID
- STUDY-20-00230
- Other IDs
- 19-1382-00001-01-PD
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
- ClinicalTrials.gov ID
- NCT05226676
- Acronym / sponsor ID
- STUDY-20-00230
- Conditions
- Spinal Cord Injuries, Neuralgia, Chronic Pain
- Keywords
- Spinal Cord Injuries, Neuropathic, Chronic Pain, Transcranial Magnetic Stimulation, Neural Plasticity, Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI left the institution and the study couldn't be transfer to a new PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Feb 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.
Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. There is a critical need to develop a new generation of therapies. Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. However there is not enough evidence of what are the long lasting effects of the different protocols. In this study, 30 SCI subjects with CNP in their hands will participate in the study. The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rTMS) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.This will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive TMS protocol (20Hz). The protocol will be done daily for two weeks. Clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded sham controlled study
| Arm | Type | Receives |
|---|---|---|
| Real rTMS group | Experimental | Device: Transcranial Magnetic StimulationRepetitive TMS at 20Hz frequency over the M1 will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). The rTMS will be applied through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. This protocol was developed in accordance with the guidelines for the safe use of rTMS. |
| Sham group | Sham comparator | Device: Transcranial Magnetic StimulationSham stimulation will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). For the sham stimulation a sham coil will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord.
- cervical lesion.
- CNP in the upper extremity.
- pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the NPS both screening (baseline) and randomization (pre-evaluation).both screening (baseline) and randomization (pre-evaluation).
- stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transcranial Magnetic StimulationTranscranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows the brain excitability to change based on Faraday's Law of Electromagnetic induction . Since the presentation of the CNP is usually bilateral, the coil will be targeting the dominant hand abductor pollicis brevis (APB) muscle. If the pain is more intense in one of the arms, that arm will be targeted. This protocol was developed in accordance with the guidelines for the safe use of rTMS. | Device | Real rTMS group, Sham group |
Primary outcome
Neuropathic Pain Scale (NPS)
Time frame: 6 weeks
This scale was developed to assess both the quantitative and qualitative qualities of NP. It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total scale from 0-10, with higher score indicating more pain.
14 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: 6 weeks
Short-Form McGill Pain Questionnaire. (SF-MPQ)
Time frame: 6 weeks
Present Pain Intensity (PPI) index
Time frame: 6 weeks
Visual Analogue Scale (VAS)
Time frame: 6 weeks
The American Spinal Injury Association Impairment Scale (ASIA scale)
Time frame: 6 weeks
Spinal cord independence measure (SCIM III)
Time frame: 6 weeks
Modified Ashworth Scale (MAS)
Time frame: 6 weeks
Beck Depression Inventory (BDI)
Time frame: 6 weeks
Patient's Global Impression of Change (PGIC)
Time frame: 6 weeks
Resting Motor Threshold (RMT)
Time frame: 6 weeks
Recruitment curve (RC)
Time frame: 6 weeks
Short intracortical inhibition (SICI)
Time frame: 6 weeks
Silent period (SP):
Time frame: 6 weeks
Sensory threshold (ST):
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Mar Cortes, M.D. principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Spinal Cord Injuries and Neuralgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 6 inclusion and 0 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: withdrawn, as of the sponsor's last update on 4 Aug 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Neuropathic Pain Scale (NPS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2023.