AutismDOUPANCT02277756
Pain in Adults With Autism Spectrum Disorder
A study testing thermode in people with Autism and Pain, run by University Hospital, Brest at 1 site in France.
Trial summary
Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- thermode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2015to 5 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
- sibling without autism or developmental disorder
- Non-specific Exclusion Criteria:
- chronic pain
- pregnancy, breast feeding
- consent form no signed
Who cannot join
- diagnosis of autism or developmental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuromodulation in Adults With Autism Spectrum Disorder
Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.
Read the detailed description
Adults with autism without intellectual disability (IQ > 85) are matched with members of siblings and control group (sex and chronological age).
Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.
Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).
- Being tested
- thermode
- Keywords
- high functioning autism, endogenous modulation systems
- Medical subject headings
- Autistic Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermodeDevice
thermal stimulation with test thermode
| Study group | Role | What they receive |
|---|---|---|
| high functioning Autism | Experimental | Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with high functioning Autism Receives: Device: thermode |
| witness | Placebo comparator | Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness Receives: Device: thermode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed by Computerized Visual analog scale
Measured: one day
Secondary outcomes (3)
salivary cortisol
Measured: one day
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
Measured: one day
heart rate variability
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study start29 May 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Why it stopped: autistic recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gildas L'HEVEDER, Doctor, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277756
- Sponsor's protocol ID
- DOUPA (RB 14.035)
- Acronym
- DOUPA
- Status last verified
- Oct 2017
- First submitted
- 21 Oct 2014
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuromodulation in Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02277756
- Acronym / sponsor ID
- DOUPA / DOUPA (RB 14.035)
- Keywords
- high functioning autism, endogenous modulation systems
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: autistic recruitment problems
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 29 May 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.
Detailed description
Adults with autism without intellectual disability (IQ > 85) are matched with members of siblings and control group (sex and chronological age).
Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.
Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high functioning Autism | Experimental | Device: thermodeThermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with high functioning Autism |
| witness | Placebo comparator | Device: thermodeThermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
- sibling without autism or developmental disorder
- chronic pain
- pregnancy, breast feeding
- consent form no signed
Key exclusion criteria (1 listed)
- diagnosis of autism or developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermodethermal stimulation with test thermode | Device | high functioning Autism, witness |
Primary outcome
Pain as assessed by Computerized Visual analog scale
Time frame: one day
3 secondary outcomes
salivary cortisol
Time frame: one day
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
Time frame: one day
heart rate variability
Time frame: one day
Results and safety
The study was stopped early (reason given: autistic recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gildas L'HEVEDER, Doctor principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermode in people with Autism and Pain, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: autistic recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as assessed by Computerized Visual analog scale (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.