CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Active· 60 target
Drug / intervention
Two-point discrimination training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03686748
NCT03686748Early Ph 1ActiveOn TrackUpdated 17mo ago

Retuning the Nervous System in Youth With Chronic Pain

Children's Hospital Medical Center, Cincinnati·interventional·Posted Sep 27, 2018·Updated Jan 6, 2025

In Brief

A Early Phase 1 clinical trial evaluating Two-point discrimination training and One-point discrimination training for Ehlers-Danlos Syndrome (EDS) and 5 related conditions. Active but no longer recruiting, targeting 60 participants across 1 site.

Detailed Summary

SPECIFIC AIMS Pain in both youth and adults is a complex, subjective and personal experience, and remains poorly understood. One particularly perplexing dimension of some forms of pain is the tendency of pain to spread outside of an affected body site to adjacent location, and then to unaffected body sites. Such widespread pain may reflect an altered spatial tuning of somatosensory processing, such that lateral inhibition is diminished, thereby allowing pain to spread. To date, no therapies exist which are designed specifically to diminish or even reverse the spatial spread of pain. However, training in two-point discrimination holds the potential to retune spatial aspects of somatosensory processing and may represent a novel therapy for widespread pain. Thus, the present investigation will test the following aims: Aim 1. Do youth with chronic pain have disrupted spatial tuning of somatosensory processing? Deficits in two point tactile discrimination have long been noted in adults with chronic pain, but such deficits remain poorly documented in pediatric chronic pain patients. In order to determine if such deficits exist, youth with both chronic pain and healthy youth will undergo assessment of two point discrimination thresholds. Aim 2. Does two-point discrimination training result in diminished pain and disability in youth with somatic pain? After initial characterization of tactile discrimination thresholds, youth with chronic pain will participate in multiple sessions of either two-point discrimination training or a single-point spatially-directed attentional control condition. Training will involve up to 9 additional sessions. Efficacy of training will be assessed by 1) reductions in the spatial extent of pain, 2) reductions in pain intensity and unpleasantness, and 3) reductions in pain-related disability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1Active
201920202021202220232024202520262027
First PostedSep 27, 2018
Enrollment StartJul 21, 2018
Primary CompletionJul 17, 2026
Study CompletionJul 16, 2027
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 7.8 years agoPrimary completion in 15 days

Interventions

Two-point discrimination trainingbehavioral

Patients will undergo multiple sessions of two-point discrimination training.

One-point discrimination trainingbehavioral

Patients will undergo multiple sessions of one-point discrimination training.