Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain

NCT ID: NCT06010251

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2026-10-20

Brief Summary

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The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.

Detailed Description

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Conditions

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Spinal Cord Injuries Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCI with pain

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

Group Type EXPERIMENTAL

tDCS and bodily illusions

Intervention Type OTHER

Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.

Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.

Interventions

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tDCS and bodily illusions

Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.

Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

SCI with Pain:

1. Men or women
2. fluent in English
3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion Criteria

Participants will be excluded if they have:

1. Major psychiatric disease/disorder (self-reported);
2. a significant neurological trauma (self-reported) other than SCI;
3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
4. history of visual and hearing loss not corrected
5. history of epilepsy or seizures
6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Eva Widerstrom-Noga

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Widerstrom-Noga, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eva Widerstrom-Noga, PhD

Role: CONTACT

(305)243-7125

Roberta Vastano, PhD

Role: CONTACT

754 207 3627

Facility Contacts

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Eva Widerstrom-Noga, PhD

Role: primary

305-243-7125

Roberta Vastano, PhD

Role: backup

7542073627

Other Identifiers

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SC220073

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20230447

Identifier Type: -

Identifier Source: org_study_id

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