Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in contact-heat evoked potentials amplitude
Study Overview
Brief Summary
Several studies have demonstrated that direct currents delivered through the skin at the level of the lumbar spinal cord can influence spinal cord function. In human volunteers, anodal lumbar transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known.
Detailed Description
The investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and lumbar tsDCS. This study will be a double-blinded, sham-controlled, cross-over trial. Each participant will undergo two experimental sessions (anodal cervical tsDCS and sham lumbar tsDCS vs. sham cervical tsDCS and anodal lumbar tsDCS), separated by at least one week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy young adults
Exclusion Criteria
- •Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
- •Use of any medication (except contraception)
Arms & Interventions
Anodal tsDCS (cervical active, lumbar sham)
Participants will receive:
- 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level.
- sham tsDCS at the lumbar level.
Intervention: Starstim (Neuroelectrics) (Device)
Anodal tsDCS (cervical sham, lumbar active)
Participants will receive:
- 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level.
- sham tsDCS at the cervical level.
Intervention: Starstim (Neuroelectrics) (Device)
Outcomes
Primary Outcomes
Change in contact-heat evoked potentials amplitude
Time Frame: Change from Baseline, at 15-minutes after the end of stimulation
N2/P2 amplitude
Secondary Outcomes
- Change in temporal summation of pain(Change from Baseline, at 15-minutes after the end of stimulation)
- Change in intensity of perception to mechanical pinprick nociceptive stimuli(Change from Baseline, at 15-minutes after the end of stimulation)
- Change in intensity of perception to contact-heat nociceptive stimuli(Change from Baseline, at 15-minutes after the end of stimulation)