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

Investigating the role of nicotinic neuromodulation in levodopa-induced dyskinesias â?? a multimodal study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029965
Enrollment
76
Registered
2020-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: Nicotine patch: 14mg/24hr nicotine patch applied for about 6-8 hours Control Intervention1: placebo skin patch: placebo patch

Sponsors

National Brain Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - non-smoker ( >10 years) - able to provide informed consent

Exclusion 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 - 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.

Design outcomes

Primary

MeasureTime frame
Motor cortical inhibition, Motor cortical plasticityTimepoint: baseline, 4 hours after patch, 1 hour after levodopa medication

Secondary

MeasureTime frame
cortical connectivity cortical reactivityTimepoint: baseline, 4 hours after patch, 1 hour after levodopa

Countries

India

Contacts

Public ContactNivethida T

National Brain Research Centre (NBRC)

dr.nivethida@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026