Multisensory Body-Representation Therapy for Spinal Cord Injury Pain

Overseen By Roberta Vastano, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Major psychiatric disorder, Neurological trauma, Alcohol or drug abuse, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2-4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining bodily illusions with transcranial direct current stimulation (tDCS) in reducing pain and improving sensory functions for individuals with spinal cord injuries (SCI) who experience ongoing neuropathic pain. Participants will engage in 10 sessions over 2-4 weeks, using techniques that may alleviate their pain. This study may suit individuals with a spinal cord injury above the waist level and moderate to severe neuropathic pain that began at least three months ago. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this therapy is safe for spinal cord injury pain?

Research has shown that using transcranial direct current stimulation (tDCS) with visual tricks can be safe and effective for managing pain after spinal cord injuries. Studies have found that participants experienced less nerve pain when using tDCS and visual illusions. Importantly, these studies did not report any serious side effects, indicating that the treatment is well-tolerated.

While tDCS is generally considered safe, some individuals might experience mild sensations like tingling or itching on the skin where the electrodes are placed. These effects are usually temporary and resolve quickly. Overall, current research supports this combined approach as a safe method for reducing pain in people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of transcranial direct current stimulation (tDCS) and bodily illusions for treating spinal cord injury pain because it offers a novel approach distinct from current methods like medications or physical therapy. Unlike traditional treatments that often focus on managing symptoms through drugs, this therapy works by retraining the brain's perception of the body, potentially altering how pain is experienced. The use of bodily illusions to create multisensory experiences, combined with non-invasive brain stimulation via tDCS, opens up a new avenue for transforming pain management in a way that might reduce reliance on medications and their associated side effects.

What evidence suggests that this therapy is effective for spinal cord injury pain?

Research has shown that transcranial direct current stimulation (tDCS) combined with body illusions can help manage nerve pain in people with spinal cord injuries. In this trial, participants will undergo a combined intervention of tDCS and bodily illusions. Studies have found that this combination reduces pain by altering brain processing. This method uses mild electrical currents and visual tricks to change how the brain perceives the body and pain. Early results indicate that patients experience less pain after these treatments. This evidence supports the potential effectiveness of tDCS and body illusions for managing nerve pain following a spinal cord injury. ^{1 2 3 4 5}

Who Is on the Research Team?

Eva Widerstrom-Noga, PhD, DDS

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for English-speaking men and women aged 18-70 who have a spinal cord injury above the L1 level and suffer from persistent neuropathic pain of at least moderate severity. Candidates should not have epilepsy, major psychiatric disorders, other significant neurological trauma, recent substance abuse issues, uncorrected vision or hearing loss, or certain metal implants.

Inclusion Criteria

I am fluent in English.

I have had nerve pain for at least 3 months, with a pain level of 4 or more.

Exclusion Criteria

I have a history of epilepsy or seizures.

You have a serious mental health condition.

You have experienced a serious brain or spinal cord injury, other than what you have told us about.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions

2-4 weeks

10 sessions total

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS and bodily illusions

Trial Overview The study is testing whether combining bodily illusions with a brain stimulation technique called transcranial direct current stimulation (tDCS) can reduce neuropathic pain and improve sensory functions in people with spinal cord injuries.

How Is the Trial Designed?

Group I: SCI with pain Experimental Treatment 1 Intervention

Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).

tDCS and bodily illusions is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Transcranial Direct Current Stimulation for:

• Neuropathic pain
• Chronic pain management

Approved in United States as tDCS for:

• Neuropathic pain
• Chronic pain management
• Rehabilitation

Approved in Canada as Transcranial Direct Current Stimulation for:

• Neuropathic pain
• Chronic pain management

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 18 spinal cord injury patients with neuropathic pain, a 2-week treatment of transcranial direct current stimulation (tDCS) combined with visual illusion (VI) led to a significant 50% reduction in pain intensity as measured by a numerical rating scale.

The treatment also resulted in significant improvements in neurophysiological measures, including changes in contact heat-evoked potentials (CHEPs) and increased pain perception thresholds, suggesting these measures could serve as objective biomarkers for assessing treatment effects in neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of transcranial direct current stimulation with visual illusion in neuropathic pain due to spinal cord injury: an evoked potentials and quantitative thermal testing study. Kumru, H., Soler, D., Vidal, J., et al.[2012]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) is a safe and affordable non-invasive technique that is gaining traction in both research and clinical settings for its potential to enhance our understanding of neural mechanisms.

This review highlights various studies using tDCS in sensory perception and rehabilitation, indicating its versatility and effectiveness in exploring the five senses, pain, and multimodal integration, while also addressing existing limitations in the research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation as a tool in the study of sensory-perceptual processing. Costa, TL., Lapenta, OM., Boggio, PS., et al.[2018]

In a study involving 39 patients with neuropathic pain from spinal cord injury, the combination of transcranial direct current stimulation (tDCS) and visual illusion significantly reduced pain intensity more than either treatment alone.

The combined treatment not only improved overall pain perception immediately after treatment but also maintained significant benefits 12 weeks later, demonstrating its efficacy and good tolerability with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of transcranial direct current stimulation and visual illusion on neuropathic pain in spinal cord injury. Soler, MD., Kumru, H., Pelayo, R., et al.[2022]

In a study involving 130 spinal cord injury patients with neuropathic pain, a combined treatment of transcranial direct current stimulation and visual illusion significantly improved pain symptoms and overall quality of life compared to a control group.

Despite identifying five different sensory phenotypes among patients, the study found no specific phenotype that responded better to the combined treatment, indicating that the therapy's effectiveness is not dependent on sensory characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation and Visual Illusion Effect According to Sensory Phenotypes in Patients With Spinal Cord Injury and Neuropathic Pain. Soler, D., Moriña, D., Kumru, H., et al.[2021]

This randomized control trial involves 84 participants and aims to assess the efficacy of transcranial direct current stimulation (tDCS) as an adjunctive treatment for chronic pain, focusing on improving pain tolerance and subjective pain experiences.

Active tDCS, which delivers a 2mA current to specific areas of the brain, is being tested against a sham treatment over 10 sessions, highlighting its potential as a non-invasive option to enhance the effectiveness of existing non-opioid pain management therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management. Janice Jimenez-Torres, G., Weinstein, BL., Walker, CR., et al.[2018]

Anodal transcranial direct current stimulation (a-tDCS) at 2 mA significantly increased corticospinal excitability in wrist extensor muscles of individuals with chronic spinal cord injury, with a 40% increase in motor-evoked potential amplitude, while 1 mA and sham stimulation did not show this effect.

Both 1 mA and 2 mA a-tDCS improved sensory perception without any reported adverse effects, indicating that a-tDCS is a safe and effective intervention for enhancing muscle activation and sensory thresholds in patients with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity dependent effects of transcranial direct current stimulation on corticospinal excitability in chronic spinal cord injury. Murray, LM., Edwards, DJ., Ruffini, G., et al.[2022]

Cathodal transcranial direct current stimulation (tDCS) over the primary somatosensory cortex enhanced the rubber hand illusion (RHI) perception compared to anodal stimulation, suggesting that reducing somatosensory input may help integrate artificial limbs into body awareness.

Despite the differences in illusion scores, neither cathodal nor anodal tDCS significantly changed the perceived hand misplacement, indicating that the mechanism of RHI perception may rely more on the attenuation of sensory precision rather than enhancing sensory input.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of the rubber hand illusion by transcranial direct current stimulation over the contralateral somatosensory cortex. Hornburger, H., Nguemeni, C., Odorfer, T., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06010251

Utility of Multisensory Body-Representation in Spinal Cord ... The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2929331/

Effectiveness of transcranial direct current stimulation and ... Our results demonstrate that transcranial direct current stimulation and visual illusion can be effective in the management of neuropathic pain following spinal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S152659002030047X

Transcranial Direct Current Stimulation and Visual Illusion ... Our results confirm the evidence that neuromodulatory therapy, combining tDCS and VR, has beneficial effects in patients with NP after an SCI.

4. trialx.com trialx.com/clinical-trials/listings/274682/utility-of-multisensory-body-representation-in-spinal-cord-injury-sci-with-pain/

Utility of Multisensory Body-Representation in Spinal Cord ... The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01404065

Effects of Transcranial Direct Current Stimulation (tDCS) ... The investigators hypothesize that active tDCS will reduce pain in subjects with spinal cord injury when compared to sham stimulation. The investigators will ...