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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

United States1 site
  • Abilities Research Center

    New York, New York, 10029

Other trials in United States

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.

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 groups in NCT05226676
Study groupRoleWhat they receive
Real rTMS groupExperimentalRepetitive 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 groupSham comparatorSham 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.

  1. 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)
  1. Numeric Rating Scale (NRS)

    NRS to measure pain sensation, total score from 0-10, higher score indicates more intense pain.

    Measured: 6 weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted7 Feb 2022
  2. Study startAug 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Why it stopped: The PI left the institution and the study couldn't be transfer to a new PI

Resources

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)
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).

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.

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