Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI

NCT05226676 | Withdrawn FDA Device

• 2 other identifiers: STUDY-20-0023019-1382-00001-01-PD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Spinal Cord Injuries; Neuropathic; Chronic Pain; Transcranial Magnetic Stimulation; Neural Plasticity; Pain

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (14)

• Numeric Rating Scale (NRS)

  6 weeks

• Short-Form McGill Pain Questionnaire. (SF-MPQ)

  6 weeks

• Present Pain Intensity (PPI) index

  6 weeks

• Visual Analogue Scale (VAS)

  6 weeks

• The American Spinal Injury Association Impairment Scale (ASIA scale)

  6 weeks

Study Arms (2)

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.

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.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

Real rTMS group; Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Abilities Research Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Chronic Pain; Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mar Cortes, M.D.

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized double blinded sham controlled study

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals should be directed to mar.cortes@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be tbd).

Locations

US (1)