Parkinson DiseaseEarly Phase 1SCP TCI NIRSNCT02795663
Deep Brain Stimulation and Parkinson's Disease
A Early Phase 1 study testing NIRS EEG HR recording in people with Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NIRS EEG HR recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2014to Dec 2017
- Phase
- Early Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting Parkinson disease and treated by STN-DBS.
- For comparison patients: Patients treated by DBS in other target.
Who cannot join
- Patients who cannot be treated by DBS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task
- Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
- Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
- Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.
- Conditions
- Parkinson Disease
- Being tested
- NIRS EEG HR recording
- Keywords
- Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS EEG HR recordingDevice
NIRS EEG HR recording
| Study group | Role | What they receive |
|---|---|---|
| parkinson's patient stimulated at STN level | Experimental | 15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording Receives: Device: NIRS EEG HR recording |
| non STN | Experimental | 5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording Receives: Device: NIRS EEG HR recording |
| control | Experimental | 20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording Receives: Device: NIRS EEG HR recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
under " on " and " off " stimulation during a motor task.
Measured: 1 month,
Secondary outcomes (6)
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
under " on " and " off " stimulation during delay discounting task.
Measured: 1 month
Study of QUIP score (QUIP scale)
Measured: 3 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation
between patient with ICD and patient without ICD
Measured: 1 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
Measured: 1 month
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
under " on " and " off " stimulation during a motor task and a delay discounting task (in order to obtain a qualitative comparison between GPi-DBS and STN-DBS.
Measured: 1 month
Study of delayed discounting task (DDT) score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start1 Sep 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel LEFRANC, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795663
- Sponsor's protocol ID
- PI2013_843_0016
- Acronym
- SCP TCI NIRS
- Status last verified
- Sep 2025
- First submitted
- 26 May 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
Publications
Mahmoudzadeh M, Wallois F, Tir M, Krystkowiak P, Lefranc M. Cortical hemodynamic mapping of subthalamic nucleus deep brain stimulation in Parkinsonian patients, using high-density functional near-infrared spectroscopy. PLoS One. 2021 Jan 25;16(1):e0245188. doi: 10.1371/journal.pone.0245188. eCollection 2021.
PubMed 33493171
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task
- ClinicalTrials.gov ID
- NCT02795663
- Acronym / sponsor ID
- SCP TCI NIRS / PI2013_843_0016
- Conditions
- Parkinson Disease
- Keywords
- Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jun 2016 (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.
- Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
- Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
- Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parkinson's patient stimulated at STN level | Experimental | Device: NIRS EEG HR recording15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording |
| non STN | Experimental | Device: NIRS EEG HR recording5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording |
| control | Experimental | Device: NIRS EEG HR recording20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting Parkinson disease and treated by STN-DBS.
- For comparison patients: Patients treated by DBS in other target.
Key exclusion criteria (1 listed)
- Patients who cannot be treated by DBS
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 |
|---|---|---|
| NIRS EEG HR recordingNIRS EEG HR recording | Device | control, non STN, parkinson's patient stimulated at STN level |
Primary outcome
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Time frame: 1 month,
under " on " and " off " stimulation during a motor task.
6 secondary outcomes
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Time frame: 1 month
Study of QUIP score (QUIP scale)
Time frame: 3 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation
Time frame: 1 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
Time frame: 1 month
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
Time frame: 1 month
Study of delayed discounting task (DDT) score
Time frame: 3 months
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 19 Sep 2025.
- Results publication: PubMed 33493171Mahmoudzadeh M, Wallois F, Tir M, Krystkowiak P, Lefranc M. Cortical hemodynamic mapping of subthalamic nucleus deep brain stimulation in Parkinsonian patients, using high-density functional near-infrared spectroscopy. PLoS One. 2021 Jan 25;16(1):e0245188. doi: 10.1371/journal.pone.0245188. eCollection 2021.
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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.
Michel LEFRANC, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NIRS EEG HR recording in people with Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens 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 2 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: finished, as of the sponsor's last update on 19 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) (time frame: 1 month,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795663, which also lists 1 linked publication.
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 19 Sep 2025.