Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain

University of Miami

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: Transcranial direct electrical stimulation (tDCS); Other: Sham Transcranial Direct Electrical Stimulation (tDCS); Other: Bodily Illusions (BI) Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04578574

20200841

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
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

1. Major psychiatric disease/disorder (self-reported)
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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

BI-TDCS Stimulation Group

Experimental group

Description:

Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.

Treatment:

Other: Bodily Illusions (BI) Procedure

Device: Transcranial direct electrical stimulation (tDCS)

BI-TDCS (Sham) Stimulation Group

Sham Comparator group

Description:

Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.

Treatment:

Other: Bodily Illusions (BI) Procedure

Other: Sham Transcranial Direct Electrical Stimulation (tDCS)