Investigating the use of nicotine for treating complications of levodopa therapy in Parkinsons disease

Not yet recruiting

Brief Summary: Parkinsonâ€™sdisease is a progressive neurodegenerative disease characterized mainly byinvoluntary movements in the form of tremors, rigidity, bradykinesia andpostural instability. As of now, there is no permanent cure to this conditiondescribed in the medical literature till date. Even the most effective medication available today (levodopa) can havevery disabling side effects. Many patients receiving treatment for Parkinsonâ€™sdisease experience abnormal involuntary movements (levodopa-induced dyskinesias, LID), which isone of the major side effects of the medication they take. In this study, we willinvestigate the cause of such abnormal involuntary movements that occur inParkinsonâ€™s disease patients during the course of the treatment. We want tounderstand why this side effect occurs and if nicotine can be used to preventits occurrence or reduce its severity.Wewill determine the structural and functional changes in the brain caused bynicotine skin patch using several non-invasive methods such as transcranialmagnetic stimulation, electroencephalography, and magnetic resonance imagingand correlate them with clinical and behavioral measures. We expect that theresults of this study will help us to understand the disease better and improvecurrent treatment options.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

The subjects may not be eligible to participate if he/she.
Has any neurological disorder (except PD in the patient group) -Has a current depressive episode, schizophrenia or bipolar disorder (self-declared and screened with GHQ-12 (Goldberg et al., 1978; Qin et al., 2018)) -Has had any head injury with loss of consciousness.
Has had any seizures in the past -Has cognitive impairment (Mini Mental Status Examination (MMSE) test score<25) -Abuses drugs/alcohol -Is pregnant or nursing Subjects will not be eligible for MRI scanning if they.
Have non-MRI compatible metal in the body such as a cardiac pacemaker, brain stimulator, surgical metal, cochlear implants, artificial heart valves or dental implants. -Are unable to lie flat on the back for the duration of the scan. -Have uncontrollable head movements. -Are claustrophobic. Subjects will not be eligible to undergo TMS if they â€“ -Have metal implants in the body such as brain stimulator, surgical metal, cochlear implants, cardiac pacemaker, intracardiac lines, implanted pumps or stimulators.

Primary Outcome Measures

Name	Time	Method
Motor cortical inhibition, Motor cortical plasticity	baseline, 4 hours after patch, 1 hour after levodopa medication

Secondary Outcome Measures

Name	Time	Method
cortical connectivity	cortical reactivity

Locations (1): National Brain Research Centre (NBRC)
🇮🇳
Gurgaon, HARYANA, India
National Brain Research Centre (NBRC)
🇮🇳Gurgaon, HARYANA, India
Dr Nivethida T
Principal investigator
dr.nivethida@gmail.com