Parkinson's Disease (Disorder) Clinical Trial
— PSYCHOSTIMOfficial title:
Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale
| NCT number | NCT04608123 |
| Other study ID # | 0 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2020 |
| Est. completion date | July 21, 2020 |
| Verified date | July 2020 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | July 21, 2020 |
| Est. primary completion date | July 21, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Parkinson's disease - Treatment with Bilateral STN DBS - Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Grenoble | Grenoble | Isère |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
Abbes M, Lhommée E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pélissier P, Seigneuret É, Chabardès S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's d — View Citation
Azulay 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. Review. — View Citation
Hogg 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. Review. — View Citation
Kurtis 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. eCollecti — View Citation
Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommée 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. d — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 months after surgery | |
| Secondary | 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) |
12 months | |
| Secondary | 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) |
12 months | |
| Secondary | 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 |
12 months | |
| Secondary | 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) |
12 months | |
| Secondary | Neuropsychiatric Fluctuations and Dopaminergic Therapy | Changing in pre-postop NFS scores correlated with:
- Preoperative versus postoperative Levodopa equivalent dose (LEDD) |
12 Months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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