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NCT06693466Not yet recruiting

Huntington's Disease and Pain

Pain Processing and Pain Assessment in Huntington's Disease a Pilot Study

Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The primary objective of this pilot study is to assess the feasibility of three internationally agreed pain test batteries in patients with Huntington Disease. The pain test batteries are developed to collect data about the facial expression of pain, body movements and vocalization of (non-) painful stimuli, and to collect data for testing the pain inhibition and facilitation. The study population will include 20 patients with genetically confirmed, adult-onset HD, in stage 1 (n=10) and stages 2 - 3 of HD (n = 10).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
5 Nov 2024
Start date
Jan 2025
Primary completion date
Dec 2025
Lead sponsor
Leiden University Medical Center
NCT number
NCT06693466

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From Jan 2025 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients in the late stage of the disease (UDHRS-TFC score \<3).
  • Have medical, psychiatric, or other conditions (other than HD) that, according to the investigator, may compromise the patient's ability to understand the patient information sheet, to give informed consent, to comply with all study requirements, or to perform study assessments.
  • Have a history of (in the past year) or current (ab)use of any drug, alcohol or medication that, in the opinion of the investigator, may seriously interfere with the primary objectives of the study.

Age

  • Juvenile and Pediatric Huntington's Disease (age at onset \<21 years).

Other

  • The presence of a sensorimotor neuropathy or any another disturbance significantly disturbing the somatosensory systems, based on medical history and/or clinical examination, that can interfere with the pain test battery.
  • Women who are pregnant or breastfeeding

Who the study is looking for

  • Genetically and clinically confirmed Adult-onset HD patients (≥ 21 years, CAG repeats ≥ 36; DCL of 4).
  • Good general health apart from having HD. Note: Patients with chronic illness (e.g. hypertension) will be eligible if the illness is stable and well-controlled according to the investigator that will not impact the primary objectives of the study.
  • Able to give written informed consent

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Leiden University Medical Center
Coordinator of this site? Confirm its status
LeidenNetherlandsUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.