Huntington's Disease and Pain

NCT06693466 | Not Yet Recruiting

• 1 other identifier: P24.014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Huntington Disease; Pain

Keywords

Huntington's disease; Pain; Pain processing; Pain facilitation; Pain inhibition; Pain Assessment in Impaired Cognition (PAIC15)

Outcome Measures

Primary Outcomes (1)

• The feasibility of a comprehensive experimental design including three different experimental pain protocols in patients with Huntington's Disease

  A screening tool was developed to determine whether the comprehensive experimental design, with three various experimental pain protocols, is feasible in patients with HD. After each assessment, the screening tool will be scored. Each item of the screening tool represents an important part of the experimental pain protocol. A 'cut-off' score ranging from 60% to 80% was adopted for each item, indicating the minimum score to be met to consider as feasible for that specific part of the experimental pain protocol. The comprehension of the instructions, duration and the completion of the study are examples of items which will be evaluated.

  Baseline assessment

Other Outcomes (6)

• Psychometric properties of the Pain Assessment in Impaired Cognition- 15

  Baseline assessment - 15 minutes

• Overall facial expression of pain in patients with HD

  Baseline assessment - 15 minutes

• Conditioned pain modulation

  Baseline assessment - 15 minutes

Study Arms (2)

Adult-onset HD stage 1

The adult-onset HD stage 1 group (total function capacity 11-13) include 10 participants. The subjects will be undergo three different pain test batteries .

Other: Facial expression block; Other: Conditioned pain modulation block; Other: Pain facilitation block

Adult-onset HD stage 2-3

The adult-onset HD stage 2-3 group (total function capacity 3-10) include 10 participants. The subjects will be undergo three different pain test batteries .

Other: Facial expression block; Other: Conditioned pain modulation block; Other: Pain facilitation block

Interventions

Facial expression block OTHER

Data will be collected to assess the facial expression, body movements and vocalization of (non-) painful heat stimuli. The experiment includes individually tailored and randomly administered painful (perceived as moderate pain) and non-painful heat stimuli.

Adult-onset HD stage 1; Adult-onset HD stage 2-3

Conditioned pain modulation block OTHER

The conditioned pain modulation will be tested according to internationally agreed standards and includes a painful phasic heat (test stimulus) and a painful tonic cold stimulus (conditioning stimulus).

Adult-onset HD stage 1; Adult-onset HD stage 2-3

Pain facilitation block OTHER

Pain facilitation will be assessed by using painful mechanical pinprick stimuli. The magnitude of pain experienced after a single mechanical pinprick stimulus is compared to that of a train of 10 pinprick stimuli of the same force.

Adult-onset HD stage 1; Adult-onset HD stage 2-3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Genetically and clinically confirmed adult-onset HD patients (AoHD) (clinical onset ≥ 21 years, CAG repeats ≥ 36, Diagnostic Confidence Level \[DCL\] of 4\]), in stage 1 (n=10 \[named as HD 1\]), stage 2 and 3 of HD (n = 10 \[named as HD 2\]), according to the Shoulson-Fahn system. Total Function Capacity (TFC) of the Unified Huntington Disease Rating Scale (UHDRS) will be used to define the HD groups: UHDRS-TFC score 11-13 (stage 1), 7-10 (stage 2), 3-6 (stage 3), 1-2 (stage 4) and a score of 0 (stage 5).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• European Huntington's Disease Network: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (5)

• Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.

  PMID: 22480803 BACKGROUND

• Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.

  PMID: 25330039 BACKGROUND

• Kunz M, Chatelle C, Lautenbacher S, Rainville P. The relation between catastrophizing and facial responsiveness to pain. Pain. 2008 Nov 15;140(1):127-134. doi: 10.1016/j.pain.2008.07.019. Epub 2008 Sep 9.

  PMID: 18783885 BACKGROUND

• Kunz M, de Waal MWM, Achterberg WP, Gimenez-Llort L, Lobbezoo F, Sampson EL, van Dalen-Kok AH, Defrin R, Invitto S, Konstantinovic L, Oosterman J, Petrini L, van der Steen JT, Strand LI, de Tommaso M, Zwakhalen S, Husebo BS, Lautenbacher S. The Pain Assessment in Impaired Cognition scale (PAIC15): A multidisciplinary and international approach to develop and test a meta-tool for pain assessment in impaired cognition, especially dementia. Eur J Pain. 2020 Jan;24(1):192-208. doi: 10.1002/ejp.1477. Epub 2019 Oct 13.

  PMID: 31487411 BACKGROUND

• de Waal MWM, van Dalen-Kok AH, de Vet HCW, Gimenez-Llort L, Konstantinovic L, de Tommaso M, Fischer T, Lukas A, Kunz M, Lautenbacher S, Lobbezoo F, McGuire BE, van der Steen JT, Achterberg WP. Observational pain assessment in older persons with dementia in four countries: Observer agreement of items and factor structure of the Pain Assessment in Impaired Cognition. Eur J Pain. 2020 Feb;24(2):279-296. doi: 10.1002/ejp.1484. Epub 2019 Oct 22.

  PMID: 31520424 BACKGROUND

MeSH Terms

Conditions

Huntington Disease; Pain

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne de Bot, MD Phd

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Sprenger, Msc

CONTACT

+31 71 526 54 42; g.p.sprenger@lumc.nl

Susanne de Bot, MD, Phd

CONTACT

+31 71 5262197; huntingtononderzoek@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

NL (1)