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Clinical Trials/NCT05711498
NCT05711498
Enrolling by Invitation
N/A

Non-invasive Investigation of Excitability Changes in the Human Spinal Cord: the Effect of Transcutaneous Spinal Direct Current Stimulation (tsDCS) on Nociceptive Flexion Reflexes

Max Planck Research Group Pain Perception1 site in 1 country40 target enrollmentDecember 1, 2022
ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Max Planck Research Group Pain Perception
Enrollment
40
Locations
1
Primary Endpoint
Change in pain intensity rating
Status
Enrolling by Invitation
Last Updated
3 years ago

Overview

Brief Summary

The aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for lower limb NFRs, but not for upper limb NFRs. Second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsDCS do affect the NFR in a polarity-dependent manner. Third, to investigate whether tsDCS effects observed on a spinal measure (NFR) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Max Planck Research Group Pain Perception
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers between the ages of 18 and 40 years
  • Having participated in the MRI medical assessment session and consented to taking part in 3T MRI measurements in written form
  • Having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form
  • Voluntary participation and signing of the study-specific consent form

Exclusion Criteria

  • Existence of any contraindications for MRI measurements and magnetic/electric neurostimulation experiments
  • Pregnancy or breastfeeding
  • Very dry or sensitive skin (e.g., intolerance to creams/shampoos)
  • Chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
  • Scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
  • Acute sunburn in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
  • Current or recurring pain
  • Injuries to the nervous system
  • History of or current neurological or psychiatric disorders
  • Chronic diseases that require permanent medication (e.g., asthma, diabetes mellitus, etc.)

Outcomes

Primary Outcomes

Change in pain intensity rating

Time Frame: Baseline and immediately after the intervention

One rating per trial on a standard visual analogue scale (VAS); internally numbered from 0 (no sensation) to 100 (unbearable pain)

Change in skin conductance response

Time Frame: Baseline and immediately after the intervention

Amplitude maximum before onset of pain rating

Change in NFR amplitude

Time Frame: Baseline and immediately after the intervention

90-150ms for lower limb, 60-200ms for upper limb

Change in heart period acceleration

Time Frame: Baseline and immediately after the intervention

Amplitude maximum before onset of pain rating

Secondary Outcomes

  • Change in NFR area(Baseline and immediately after the intervention)

Study Sites (1)

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