NCT04608123 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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
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.
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.
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
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

Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale

Details for clinical trial NCT04608123

Clinical trial NCT04608123 - References