Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
NCT ID: NCT04578574
Last Updated: 2024-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2021-01-13
2023-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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BI-TDCS Stimulation Group
Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
Bodily Illusions (BI) Procedure
Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.
Transcranial direct electrical stimulation (tDCS)
Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI.
BI-TDCS (Sham) Stimulation Group
Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
Bodily Illusions (BI) Procedure
Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.
Sham Transcranial Direct Electrical Stimulation (tDCS)
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
Interventions
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Bodily Illusions (BI) Procedure
Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.
Transcranial direct electrical stimulation (tDCS)
Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI.
Sham Transcranial Direct Electrical Stimulation (tDCS)
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
Eligibility Criteria
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Inclusion Criteria
2. Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10).
3. Participants must be willing and able to sign informed consent
Exclusion Criteria
2. A significant neurological trauma besides SCI
3. A recent (one-year) history of alcohol or drug abuse (selfreported)
4. Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
18 Years
75 Years
ALL
No
Sponsors
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Florida
OTHER
University of Miami
OTHER
Responsible Party
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Eva Widerstrom-Noga
Research Professor
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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20200841
Identifier Type: -
Identifier Source: org_study_id
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