Neuropathic PainNCT04578574
Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
A study testing Bodily Illusions (BI) Procedure and Transcranial direct electrical stimulation (tDCS) in people with Neuropathic Pain, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Bodily Illusions (BI) Procedure and Transcranial direct electrical stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
- 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).
- Participants must be willing and able to sign informed consent
Who cannot join
- Major psychiatric disease/disorder (self-reported)
- A significant neurological trauma besides SCI
- A recent (one-year) history of alcohol or drug abuse (selfreported)
- Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
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.
- Conditions
- Neuropathic Pain
- Being tested
- Bodily Illusions (BI) Procedure, Transcranial direct electrical stimulation (tDCS), Sham Transcranial Direct Electrical Stimulation (tDCS)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodily Illusions (BI) ProcedureOther
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)Device
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)Other
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
| Study group | Role | What they receive |
|---|---|---|
| BI-TDCS Stimulation Group | Experimental | Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. Receives: Other: Bodily Illusions (BI) Procedure; Device: Transcranial direct electrical stimulation (tDCS) |
| BI-TDCS (Sham) Stimulation Group | Sham comparator | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. Receives: Other: Bodily Illusions (BI) Procedure; Other: Sham Transcranial Direct Electrical Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropathic Pain Severity
Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain.
Measured: baseline, up to two weeks
Change in Performance of Body Part Processing
Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds.
Measured: baseline, up to two weeks
Secondary outcomes (1)
Change in Sensory Thresholds
Assessed by the Quantitative Sensory Testing. Pain thresholds are evaluated using Medoc machine (Medoc Ltd,Ramat Yishai, Israel and FDA approved. It assesses participants' ability to feel change in temperature (0°C to 50°C). The temperatures in this range may be felt as cool, cold, warm, and hot. A probe is placed on the skin and it feels either cool, cold, warm or hot. Participants' thresholds are recorded for cool or warm sensation, and for cold or hot painful thresholds.
Measured: baseline, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start13 Jan 2021
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Principal investigator, Eva Widerstrom-Noga, University of Miami
- Investigators
- Eva Widerstrom-Noga, Phd, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578574
- Sponsor's protocol ID
- 20200841
- Status last verified
- Feb 2024
- First submitted
- 2 Oct 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04578574
- Acronym / sponsor ID
- 20200841
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI-TDCS Stimulation Group | Experimental | Other: Bodily Illusions (BI) Procedure, Device: Transcranial direct electrical stimulation (tDCS)Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. |
| BI-TDCS (Sham) Stimulation Group | Sham comparator | Other: Bodily Illusions (BI) Procedure, Other: Sham Transcranial Direct Electrical Stimulation (tDCS)Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
- 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).
- Participants must be willing and able to sign informed consent
Key exclusion criteria (4 listed)
- Major psychiatric disease/disorder (self-reported)
- A significant neurological trauma besides SCI
- A recent (one-year) history of alcohol or drug abuse (selfreported)
- Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodily Illusions (BI) ProcedureEach 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. | Other | BI-TDCS (Sham) Stimulation Group, BI-TDCS Stimulation Group |
| 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. | Device | BI-TDCS Stimulation Group |
| 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. | Other | BI-TDCS (Sham) Stimulation Group |
Primary outcome
Change in Neuropathic Pain Severity
Time frame: baseline, up to two weeks
Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain.
Change in Performance of Body Part Processing
Time frame: baseline, up to two weeks
Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds.
1 secondary outcome
Change in Sensory Thresholds
Time frame: baseline, up to two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Widerstrom-Noga, Phd principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodily Illusions (BI) Procedure and Transcranial direct electrical stimulation (tDCS) in people with Neuropathic Pain, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropathic Pain Severity (time frame: baseline, up to two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.