Parkinson DiseasePSYLES-STIMNCT06389903
Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease
A study testing assessment in people with Parkinson Disease, run by Centre Hospitalier du Rouvray at 1 site in France.
Trial summary
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation. The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2019to 5 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Diagnosis of Parkinson's disease (ICD-10)
- L-dopa test must be positive
- Participants who gave their informed, written consent
Who cannot join
- Severe psychiatric disorder
- Major neurocognitive disorder contraindicating surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).
Read the detailed description
The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.
- Conditions
- Parkinson Disease
- Being tested
- assessment
- Keywords
- Brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentBehavioural
post-surgery behavioral assessment using scales
| Study group | Role | What they receive |
|---|---|---|
| Behavorial Assessment | Experimental | post-surgery behavioral assessment using scales Receives: Behavioral: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of mania symptoms
The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
Measured: Baseline, 72 hours, 1 month and 3 months after surgery
Secondary outcomes (7)
Assessment of change of depressive symptoms
The variation of Hamilton Rating Scale for Depression (HAMD-21). HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).
Measured: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Behavior
The variation of the Ardouin Scale of Behavior in Parkinson's Disease. The total score ranges from 0 to 84. Higher score mean worse outcome.
Measured: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Impulsivity
The variation of the Dickman Impulsivity Inventory. It is a self report measure assessing dysfunctional impulsivity and functional impulsivity. Regarding dysfunctional impulsivity (12 items), higher score mean worse adaptation. Regarding functional impulsivity (11 items), higher score mean better adaptation.
Measured: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Apathy
The variation of the Apathy Evaluation Scale. This 18 item scale ranges from 0 to 12. Higher score means worse outcome.
Measured: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of personality
Big Five inventory. The test identified five factors as follows :
- openness to experience (inventive/curious vs. consistent/cautious)
- conscientiousness (efficient/organized vs. extravagant/careless)
- extraversion (outgoing/energetic vs. solitary/reserved)
- agreeableness (friendly/compassionate vs. critical/judgmental)
- neuroticism (sensitive/nervous vs. resilient/confident)
Measured: Baseline
Assessment of executive functions
Frontal Assessment Battery at Bedside. Thebattery consists of six subtests exploring the following: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.
Measured: Baseline, 72 hours, 3 months after surgery
Assessment of confusion
Confusion Assessment method (CAM). The CAM instrument assesses the presence, severity, and fluctuation of 9 delirium features: acute onset, inattention, disorganized thinking, altered level of consciousness, disorientation, memory impairment, perceptual disturbances, psychomotor agitation or retardation, and altered sleep-wake cycle.
Measured: 72 hours and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start4 Jun 2019
- Primary completion3 Jul 2020
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Rouvray
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389903
- Sponsor's protocol ID
- 2018-A00185-50
- Acronym
- PSYLES-STIM
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06389903
- Acronym / sponsor ID
- PSYLES-STIM / 2018-A00185-50
- Conditions
- Parkinson Disease
- Keywords
- Brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier du RouvrayOther government
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 29 Apr 2024 (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.
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).
Detailed description
The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavorial Assessment | Experimental | Behavioral: assessmentpost-surgery behavioral assessment using scales |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Diagnosis of Parkinson's disease (ICD-10)
- L-dopa test must be positive
- Participants who gave their informed, written consent
Key exclusion criteria (2 listed)
- Severe psychiatric disorder
- Major neurocognitive disorder contraindicating surgery
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 |
|---|---|---|
| assessmentpost-surgery behavioral assessment using scales | Behavioural | Behavorial Assessment |
Primary outcome
Assessment of change of mania symptoms
Time frame: Baseline, 72 hours, 1 month and 3 months after surgery
The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
7 secondary outcomes
Assessment of change of depressive symptoms
Time frame: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Behavior
Time frame: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Impulsivity
Time frame: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of change of Apathy
Time frame: Baseline, 72 hours, 1 month and 3 months after surgery
Assessment of personality
Time frame: Baseline
Assessment of executive functions
Time frame: Baseline, 72 hours, 3 months after surgery
Assessment of confusion
Time frame: 72 hours and 3 months after surgery
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 29 Apr 2024.
- 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 assessment in people with Parkinson Disease, run by Centre Hospitalier du Rouvray 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 4 inclusion and 2 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 29 Apr 2024. 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.
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?
Assessment of change of mania symptoms (time frame: Baseline, 72 hours, 1 month and 3 months after surgery). 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 29 Apr 2024.