| CTRI Number |
CTRI/2020/12/029965 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Investigating the use of nicotine for treating complications of levodopa therapy in Parkinsons disease |
|
Scientific Title of Study
|
Investigating the role of nicotinic neuromodulation in levodopa-induced dyskinesias – a multimodal study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivethida T |
| Designation |
DBT/WT India Alliance Clinical Research Fellow |
| Affiliation |
National Brain Research Centre (NBRC) |
| Address |
Room no.8, First floor, MRI building, National Brain Research Centre (NBRC), NH-8, Nainwal Mode, Manesar, Haryana 122052
Gurgaon
HARYANA
122052
India |
| Phone |
|
| Fax |
|
| Email |
dr.nivethida@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivethida T |
| Designation |
DBT/WT India Alliance Clinical Research Fellow |
| Affiliation |
National Brain Research Centre (NBRC) |
| Address |
Room No.8, First floor, MRI building, National Brain Research Centre (NBRC), NH-8, Nainwal Mode, Manesar, Haryana 122052
Gurgaon
HARYANA
122052
India |
| Phone |
|
| Fax |
|
| Email |
dr.nivethida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivethida T |
| Designation |
DBT/WT India Alliance Clinical Research Fellow |
| Affiliation |
National Brain Research Centre (NBRC) |
| Address |
Room No.8, First floor, MRI building, National Brain Research Centre (NBRC), NH-8, Nainwal Mode, Manesar, Haryana 122052
Gurgaon
HARYANA
122052
India |
| Phone |
|
| Fax |
|
| Email |
dr.nivethida@gmail.com |
|
|
Source of Monetary or Material Support
|
| DBT/WT India Alliance
526, DLF Tower A, Jasola District Centre Behind Apollo Hospital, New Delhi - 110025 |
|
|
Primary Sponsor
|
| Name |
National Brain Research Centre |
| Address |
National Brain Research Centre (NBRC), NH-8, Nainwal Mode, Manesar, Haryana 122052 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivethida T |
National Brain Research Centre (NBRC) |
Human Motor Neurophysiology and Neuromodulation Lab, Ground floor, MRI building, NH-8, Nainwal Mode, Manesar
Gurgaon
HARYANA |
0124-2845253
dr.nivethida@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee, National Brain Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy controls |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nicotine patch |
14mg/24hr nicotine patch applied for about 6-8 hours |
| Comparator Agent |
placebo skin patch |
placebo patch |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- non-smoker (>10 years)
- able to provide informed consent |
|
| ExclusionCriteria |
| Details |
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 –
- Have metal implants in the body such as brain stimulator, surgical metal, cochlear implants, cardiac pacemaker, intracardiac lines, implanted pumps or stimulators.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor cortical inhibition, Motor cortical plasticity |
baseline, 4 hours after patch, 1 hour after levodopa medication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
cortical connectivity
cortical reactivity |
baseline, 4 hours after patch, 1 hour after levodopa |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.nivethida@gmail.com].
- For how long will this data be available start date provided 01-01-2022 and end date provided 31-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Parkinson’s
disease is a progressive neurodegenerative disease characterized mainly by
involuntary movements in the form of tremors, rigidity, bradykinesia and
postural instability. As of now, there is no permanent cure to this condition
described in the medical literature till date.
Even the most effective medication available today (levodopa) can have
very disabling side effects. Many patients receiving treatment for Parkinson’s
disease experience abnormal involuntary movements (levodopa-induced dyskinesias, LID), which is
one of the major side effects of the medication they take. In this study, we will
investigate the cause of such abnormal involuntary movements that occur in
Parkinson’s disease patients during the course of the treatment. We want to
understand why this side effect occurs and if nicotine can be used to prevent
its occurrence or reduce its severity.
We
will determine the structural and functional changes in the brain caused by
nicotine skin patch using several non-invasive methods such as transcranial
magnetic stimulation, electroencephalography, and magnetic resonance imaging
and correlate them with clinical and behavioral measures. We expect that the
results of this study will help us to understand the disease better and improve
current treatment options.
|