An Early Phase 1 interventional study of Two-point discrimination training and One-point discrimination training in Ehlers-Danlos Syndrome (EDS), Complex Regional Pain Syndrome (CRPS) and Amplified Musculoskeletal Pain Syndrome (AMPS), sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Children's Hospital Medical Center, Cincinnati · Early Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 26 studies in Ehlers-Danlos Syndrome with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Ehlers-Danlos Syndrome · United States.
Among the 26 studies in Ehlers-Danlos Syndrome with a site in United States, this one is the 7th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2018, is the only one in phase 1, reaches primary completion later than 5 of the 10 other live ones, and was the 10th registered.
67 studies on the registry are indexed under Ehlers-Danlos Syndrome; 24 are open to participants now.
Browse Ehlers-Danlos Syndrome studies →9 of the 26 studies in Ehlers-Danlos Syndrome with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Integrative Skin Science and Research · Sites in United States
Ages 18+ · Women only · Healthy volunteers
xCures · Sites in United States
Integrative Skin Science and Research · Sites in United States
Ages 35–70 · Women only · Healthy volunteers
Brain Inflammation Collaborative · Sites in United States
Ages 2+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Ehlers-Danlos Syndrome studies recruiting now, 9 (75%) set no upper age limit and 3 (25%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 10 Years to 17 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2018.
This study's planned enrollment of 60 is close to the median of 60 across 32 interventional studies indexed under Ehlers-Danlos Syndrome.
Median enrollment 60 across the 15 interventional studies, 334 across the 11 observational. Of the 15 that completed or were terminated, 2 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 26 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Children's Hospital Medical Center, Cincinnati has 1 study filed under Ehlers-Danlos Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Ehlers-Danlos Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07464093Brigham and Women's HospitalSTABLE Pilates for Hypermobility | 2026-12 |
| NCT07743229Medical University of South CarolinaCOG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints | 2027-07-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 26 studies in Ehlers-Danlos Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 DESIGN Prior to commencing this investigation, investigators will optimize the tactile discrimination threshold testing (i.e. as per baseline visit, below), and the training conditions, in up to ten participants (patients and/or healthy controls). This will serve as a pilot to refine operational aspects of study procedures before investigators commence the main investigation proposed herein. Following this, youth with either chronic pain (ages 10-17, n=40) or healthy youth (ages 10-17, n=20) will undergo assessments of two-point and single-point discrimination thresholds in an initial session (Aim 1). After this initial session, youth with chronic pain will participate in up to 9 additional sessions of attentional training (Aim 2). These chronic pain patients will be randomized to either two-point discrimination training (n=20) or a single-point spatially-directed attentional control condition (n=20). Participants will not be informed of which intervention they will receive (single-blind study). Psychological questionnaires will be completed in the first and last sessions in order to determine how these variables relate to tactile discrimination and response to training.
STUDY INTERVENTIONS 5.1 Two Point Discrimination Training: Two-point discrimination threshold (TPD) training may be performed 1) at spatial locations remote from pain, 2) at spatial locations adjacent to the region of pain, and/or 3) at spatial locations in the site of pain, if the participant will tolerate it. TPD is defined as the smallest distance between two points at which someone can recognize two points, and not one, touching their skin. As such this is a test of one's ability to identify separate stimulation of two discrete areas, and relies heavily on lateral inhibition. Highly precise mechanical calipers will be gently placed onto the skin and the distance between the prongs will be increased/decreased. After repeated decreases and increases in the distance between the prongs, the TPD will be deemed as the distance at which participants consistently report two points instead of one. One-point stimuli will be interleaved to serve as a control condition. Participants will be informed immediately of correct and incorrect responses as part of the discrimination training.
5.2 Control Stimulation: Participants will undergo a single-point discrimination training at the same sites as described above. Probes of different sizes will be used for this portion - a small diameter probe (\~1-5 mm) and a large diameter probe (\~6-50mm). The probes will be gently placed in contact with the participants' skin, and the participant will be instructed to respond if they were contacted with the small or large probe. Participants will be informed immediately of correct and incorrect responses as part of the discrimination training.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Chronic Pain Patients:
Control Participants:
Exclusion Criteria:
Two point discrimination training.
Behavioral: Two-point discrimination training
One point discrimination of size of probe
Behavioral: One-point discrimination training
Observational component of differences in discrimination between chronic pain patients and healthy controls.
Patients will undergo multiple sessions of two-point discrimination training.
Patients will undergo multiple sessions of one-point discrimination training.
Change in spatial extent of pain from baseline visit to final visit
total area of body affected by pain
Time frame: baseline to final visit which is up to 5 weeks from baseline
Change in pain ratings from baseline visit to final visit
Ratings of current pain intensity on a non-numerical visual analog scale ranging from "not at all intense" to "most intense pain sensation imaginable" and of pain unpleasantness on a non-numerical visual analog scale ranging from "not at all unpleasant" to "most unpleasant pain imaginable".
Time frame: baseline to final visit which is up to 5 weeks from baseline
Change in pain-related disability from baseline visit to final visit
pain-related disability as assessed by the Functional Disability Index
Time frame: baseline to final visit which is up to 5 weeks from baseline
Change in two point discrimination threshold from baseline visit to final visit
Calipers moving at fixed distances to determine threshold of two point detection
Time frame: baseline to final visit which is up to 5 weeks from baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All collected deidentified IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Immediately after publication with no end date.
Access criteria: Researchers who provide a methodologically sound proposal and who sign a data sharing agreement.
Started Jul 2018 (actual). Primary completion is estimated for Jul 2026, 95 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati →