PainNCT04151043
Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
A study testing Suggestions and Deep brain stimulation in people with Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease. The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Suggestions and Deep brain stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 1 Jul 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of PD (confirmed by a neurologist)
- Bilateral implanted DBS in the STN during the study or for a minimum of 6 months
Who cannot join
- Other neurological or medical disorders (e.g. stroke, neuropathy, diabetes) or other disorders (e.g. musculoskeletal diseases) with expected influence on pain
- Dementia
- Untreated depression
- Patients unable to pause anti-parkinsonian medication
- Patients unable to cooperate
- Patients treated with painkillers except paracetamol and NSAID (except if pain and treatment is adequately stable as evaluated by a doctor)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology and Behavioural Sciences, Aarhus University
Aarhus, 8000
About this study
The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease.
The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. During pain induction and chronic pain evaluation deep brain stimulation treatment is regulated. Pain stimuli and regulation of deep brain stimulation are accompanied by verbal suggestions as to the analgesic effect of deep brain stimulation or no suggestions. During the test session patients evaluate their chronic and evoked pain and expectations.
The study procedure is repeated on two separate test days to investigate pain during deep brain stimulation treatment with or without verbal suggestions. All participants will complete all study conditions with no suggestions and verbal suggestions, respectively.
- Conditions
- Pain
- Being tested
- Suggestions, Deep brain stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuggestionsBehavioural
Verbal suggestions or no suggestions about treatment outcome
Deep brain stimulationDevice
Regulation of deep brain stimulation intensity
| Study group | Role | What they receive |
|---|---|---|
| Verbal suggestion | Other | Not described Receives: Behavioral: Suggestions; Device: Deep brain stimulation |
| No suggestion | Other | Not described Receives: Behavioral: Suggestions; Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS) (Change)
A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective chronic and evoked pain in all study conditions.
Measured: Participants will be tested on two days. The numerical rating scale will be applied to assess chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Numerical rating scale (NRS) (Change)
A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective expectations to chronic and evoked pain in all study conditions.
Measured: Participants will be tested on two days. The numerical rating scale will be applied to assess expectations to chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Secondary outcomes (1)
Unified Parkinson's Disease Rating Scale (UPDRS) (Change)
Motor symptoms related to Parkinson's disease are assessed using the Unified Parkinson's Disease Rating Scale, part III in all study conditions.
Measured: Participants will be tested on two days. The Unified Parkinson's Disease Rating Scale will be used to evaluate motor symptoms at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151043
- Sponsor's protocol ID
- UAarhus_Sophie
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04151043
- Acronym / sponsor ID
- UAarhus_Sophie
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease.
The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. During pain induction and chronic pain evaluation deep brain stimulation treatment is regulated. Pain stimuli and regulation of deep brain stimulation are accompanied by verbal suggestions as to the analgesic effect of deep brain stimulation or no suggestions. During the test session patients evaluate their chronic and evoked pain and expectations.
The study procedure is repeated on two separate test days to investigate pain during deep brain stimulation treatment with or without verbal suggestions. All participants will complete all study conditions with no suggestions and verbal suggestions, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal suggestion | Other | Behavioral: Suggestions, Device: Deep brain stimulation |
| No suggestion | Other | Behavioral: Suggestions, Device: Deep brain stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PD (confirmed by a neurologist)
- Bilateral implanted DBS in the STN during the study or for a minimum of 6 months
Key exclusion criteria (6 listed)
- Other neurological or medical disorders (e.g. stroke, neuropathy, diabetes) or other disorders (e.g. musculoskeletal diseases) with expected influence on pain
- Dementia
- Untreated depression
- Patients unable to pause anti-parkinsonian medication
- Patients unable to cooperate
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 |
|---|---|---|
| SuggestionsVerbal suggestions or no suggestions about treatment outcome | Behavioural | No suggestion, Verbal suggestion |
| Deep brain stimulationRegulation of deep brain stimulation intensity | Device | No suggestion, Verbal suggestion |
Primary outcome
Numerical rating scale (NRS) (Change)
Time frame: Participants will be tested on two days. The numerical rating scale will be applied to assess chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective chronic and evoked pain in all study conditions.
Numerical rating scale (NRS) (Change)
Time frame: Participants will be tested on two days. The numerical rating scale will be applied to assess expectations to chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective expectations to chronic and evoked pain in all study conditions.
1 secondary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) (Change)
Time frame: Participants will be tested on two days. The Unified Parkinson's Disease Rating Scale will be used to evaluate motor symptoms at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suggestions and Deep brain stimulation in people with Pain, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2023. 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 Denmark. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical rating scale (NRS) (Change) (time frame: Participants will be tested on two days. The numerical rating scale will be applied to assess chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.). The study lists 2 primary outcomes in all. 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 10 May 2023.