A Trial of tPCS on Parkinson's Disease OFF State
1 other identifier
interventional
15
1 country
1
Brief Summary
A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Sep 2019
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedAugust 13, 2019
August 1, 2019
2 years
August 9, 2019
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Unified Parkinson's disease rating scale (UPDRS) part III
The effectiveness of tPCS in OFF state of PD will be evaluated. Unified Parkinson's disease rating scale (UPDRS) part III will be applied - pre and post stimulation. UPDRS Part III is motor examination that consists of speech, facial expression, rigidity, rest tremor, postural/action tremor, rapid alternating movements for testing bradykinesia, arising from chair, posture, gait, body bradykinesia, postural stability. In each subset, minimum score is 0 and maximum is 4. By adding, total UPDRS part III score is minimum 0 to maximum 108. Higher score means more severity of parkinsonism.
3 months
Changes in spatiotemporal gait measures using objective gait analysis
Zeno Walkway Gait carpet will be used and the spatiotemporal details of the gait will be analyzed by ProtoKinetics Movement Analysis Software (PKMAS) software, pre and post stimulation.
3 months
Change in upper limb motor kinetics
KinArm will be used pre and post stimulation to have objective measurement of upper limb motor function. Reaching task will be performed using standardized KinArm protocol. Visuomotor function of upper limb will be analyzed by postural control of arm with respect to x and y co-ordinates, angular velocity, acceleration, force and torque.
3 months
Changes in Network fragmentation using Quantitative Electroencephalography (EEG)
Network fragmentation will be analyzed by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation. All frequency bands will be analyzed.
3 months
Study Arms (3)
Real tPCS
EXPERIMENTALPatients will be randomized to any of the 3 arms. In Real tPCS arm, we will give active tPCS for 20 mins.
Sham tPCS
SHAM COMPARATORPatients will be randomized to any of the 3 arms. In Sham tPCS arm, we will give sham tPCS for 20 mins.
Levodopa
ACTIVE COMPARATORPatients will be randomized to any of the 3 arms. In Levodopa arm, we will give 3 tablets of Levodopa-Carbidopa (100/25).
Interventions
Active anodal tPCS will be given for 20 mins to motor cortex (M1) or supplementary motor area (SMA), based on our quantitative EEG findings.
For the sham condition, the electrode placement will be the same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Idiopathic Parkinson's disease (IPD).
You may not qualify if:
- Parkinson plus syndromes.
- Drug-induced parkinsonism.
- Patients who cannot walk independently or wheelchair-bound.
- Patients who are not able to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Related Publications (1)
Alon G, Yungher DA, Shulman LM, Rogers MW. Safety and immediate effect of noninvasive transcranial pulsed current stimulation on gait and balance in Parkinson disease. Neurorehabil Neural Repair. 2012 Nov-Dec;26(9):1089-95. doi: 10.1177/1545968312448233. Epub 2012 May 10.
PMID: 22581566BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mandar Jog, MD
London Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 13, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share