Parkinson's Disease (Disorder)PSYCHOSTIMNCT04608123
Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease
An observational study of Parkinson's Disease (Disorder), run by University Hospital, Grenoble at 1 site in France.
Trial summary
Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (Disorder)
- What is being tested?
- none (observational study)
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 21 Jul 2020
- Phase
- Observational
- 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
- Child, Adult, Older adult
Study population: PD patients treated with DBS STN at Grenoble Hospital within September 2016 and June 2019
Who may be able to join
- Parkinson's disease
- Treatment with Bilateral STN DBS
- Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context
Who cannot join
- DBS for non PD patients
- Unilateral DBS or other DBS targets
- Patients not evaluated with NFS
- Patients with incomplete preoperative evaluation
- Patients who refused the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale
Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)
Read the detailed description
Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)
- Conditions
- Parkinson's Disease (Disorder)
- Being tested
- none (observational study)
- Keywords
- DBS, Deep Brain Stimulation, Neuropsychiatric Fluctuations, Nonmotor Fluctuations, Scale
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none (observational study)Other
DBS
| Study group | Role | What they receive |
|---|---|---|
| DBS Patients with NFS | Patients with PD treated with STN DBS between 2016 and 2019 who underwent NFS testing in pre and post-op conditions Receives: Other: none (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of DBS for Neuropsychiatric Fluctuations
Improvement of Neuropsychiatric Fluctuation Scale (NFS) Score between preoperative MED ON and MED OFF conditions versus postoperative MED ON-STIM ON and MED OFF-STIM ON conditions. NFS ON and OFF med scores are independent and they ranges from -30 to +30. Positive scores represent good outcomes (good feelings, non OFF neuropsychiatric symptoms), whereas negative scores denote the presence of negative feelings in a quantity exceeding the positive ones
Measured: 12 months after surgery
Secondary outcomes (5)
Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations
Changing in pre-post op NFS scores correlated with:
- Demographic and Clinical data: age, sex, disease duration, side onset, clinical phenotype, years passed with fluctuations, comorbidities, psychiatric history not linked to the disease or its treatment, psychiatric complications of dopaminergic therapy
- Dopaminergic treatment data: years of therapy with Levodopa, percentage of motor improvement with Levodopa-test, pre and postoperative LEDD, changing in psychiatric treatment (doses and number of medications)
- Perioperative variables: type of anaesthesia, perioperative complications
- DBS parameters: stimulation type, plots selected, amplitude, rate, duration of impulse, stereo tactical coordinates of electrodes, stimulator type (rechargeable, not rechargeable)
Measured: 12 months
Neuropsychiatric Fluctuations, Cognitive and Psychiatric state
Changing in pre-postop NFS scores correlated with:
- Cognitive evaluation scales (Mattis Scale, Score Frontal, Wisconsin Card Sorting Test - WCST, Luria manual sequencing task)
- Psychiatric evaluation scales (Beck Depression Scale - BDI-II, Evaluation Comportamentale dans la Maladie de Parkinson - ECMP, Starkstein Apathy Scale)
Measured: 12 months
Neuropsychiatric Fluctuations, preoperative and postoperative motor status
Changing in pre-postop NFS scores correlated with:
- Preoperative UPDRS III Score (total score, sub scores of tremor, rigidity, akinesia, parole, posture-gait-instability) in MED ON and MED OFF conditions
- Changing in UPDRS III Scores (total and sub scores) in preoperative MED ON and MED OFF conditions versus postoperative MED ON STIM ON and MED OFF STIM ON conditions
Measured: 12 months
Neuropsychiatric Fluctuations and other Nonmotor Symptoms
Changing in pre-postop NFS scores correlated with:
- Changing in MDS-UPDRS scores and sub scores (total, section I, section II, section IV)
Measured: 12 months
Neuropsychiatric Fluctuations and Dopaminergic Therapy
Changing in pre-postop NFS scores correlated with:
- Preoperative versus postoperative Levodopa equivalent dose (LEDD)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 May 2020
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Moro, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608123
- Sponsor's protocol ID
- 0
- Acronym
- PSYCHOSTIM
- Status last verified
- Jul 2020
- First submitted
- 22 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.
PubMed 30363450Abbes M, Lhommee E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pelissier P, Seigneuret E, Chabardes S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.
PubMed 29436490Hogg E, Wertheimer J, Graner S, Tagliati M. Deep Brain Stimulation and Nonmotor Symptoms. Int Rev Neurobiol. 2017;134:1045-1089. doi: 10.1016/bs.irn.2017.05.022. Epub 2017 Jul 3.
PubMed 28805564Kurtis MM, Rajah T, Delgado LF, Dafsari HS. The effect of deep brain stimulation on the non-motor symptoms of Parkinson's disease: a critical review of the current evidence. NPJ Parkinsons Dis. 2017 Jan 12;3:16024. doi: 10.1038/npjparkd.2016.24. eCollection 2017.
PubMed 28725706Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23.
PubMed 23263599
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale
- ClinicalTrials.gov ID
- NCT04608123
- Acronym / sponsor ID
- PSYCHOSTIM / 0
- Conditions
- Parkinson's Disease (Disorder)
- Keywords
- DBS, Deep Brain Stimulation, Neuropsychiatric Fluctuations, Nonmotor Fluctuations, Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 29 Oct 2020 (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.
Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)
Detailed description
Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS Patients with NFS | – | Other: none (observational study)Patients with PD treated with STN DBS between 2016 and 2019 who underwent NFS testing in pre and post-op conditions |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- PD patients treated with DBS STN at Grenoble Hospital within September 2016 and June 2019
Key inclusion criteria (3 listed)
- Parkinson's disease
- Treatment with Bilateral STN DBS
- Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context
Key exclusion criteria (5 listed)
- DBS for non PD patients
- Unilateral DBS or other DBS targets
- Patients not evaluated with NFS
- Patients with incomplete preoperative evaluation
- Patients who refused the use of their data
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 |
|---|---|---|
| none (observational study)DBS | Other | DBS Patients with NFS |
Primary outcome
Effectiveness of DBS for Neuropsychiatric Fluctuations
Time frame: 12 months after surgery
Improvement of Neuropsychiatric Fluctuation Scale (NFS) Score between preoperative MED ON and MED OFF conditions versus postoperative MED ON-STIM ON and MED OFF-STIM ON conditions. NFS ON and OFF med scores are independent and they ranges from -30 to +30. Positive scores represent good outcomes (good feelings, non OFF neuropsychiatric symptoms), whereas negative scores denote the presence of negative feelings in a quantity exceeding the positive ones
5 secondary outcomes
Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations
Time frame: 12 months
Neuropsychiatric Fluctuations, Cognitive and Psychiatric state
Time frame: 12 months
Neuropsychiatric Fluctuations, preoperative and postoperative motor status
Time frame: 12 months
Neuropsychiatric Fluctuations and other Nonmotor Symptoms
Time frame: 12 months
Neuropsychiatric Fluctuations and Dopaminergic Therapy
Time frame: 12 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 2 Nov 2020.
- Results publication: PubMed 30363450Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.
- Results publication: PubMed 29436490Abbes M, Lhommee E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pelissier P, Seigneuret E, Chabardes S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.
- Results publication: PubMed 28805564Hogg E, Wertheimer J, Graner S, Tagliati M. Deep Brain Stimulation and Nonmotor Symptoms. Int Rev Neurobiol. 2017;134:1045-1089. doi: 10.1016/bs.irn.2017.05.022. Epub 2017 Jul 3.
- Results publication: PubMed 28725706Kurtis MM, Rajah T, Delgado LF, Dafsari HS. The effect of deep brain stimulation on the non-motor symptoms of Parkinson's disease: a critical review of the current evidence. NPJ Parkinsons Dis. 2017 Jan 12;3:16024. doi: 10.1038/npjparkd.2016.24. eCollection 2017.
- Results publication: PubMed 23263599Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23.
- 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.
Elena Moro study director
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (Disorder), run by University Hospital, Grenoble 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 3 inclusion and 5 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 2 Nov 2020. 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?
Effectiveness of DBS for Neuropsychiatric Fluctuations (time frame: 12 months after surgery). 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 NCT04608123, which also lists 5 linked publications.
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 2 Nov 2020.