Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulation, Transcranial Direct Current Stimulation.
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder), Parkinson Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Dopaminergic medications and Deep Brain Stimulation (DBS) are the current standards interventions for Parkinson's Disease. Pharmacotherapy with dopaminergic drugs leads to partial improvement in motor functions of patients. Invasive therapies like DBS have as yet limited availability and accessibility, with risk of adverse events as well. Non invasive therapies like Transcranial Direct Current Stimulation (tDCS) are currently increasingly being probed for their therapeutic value, in view of their safety, portability and convenience of administration. Improvement in motor function immediately after a single session of tDCS has been observed. The effect of single simulation is not sustained beyond a few days. Only few studies with varied sites of stimulation have evaluated the effect of repetitive tDCS on motor function improvement in patients with Parkinson's Disease, with conflicting results. There is an unmet need to probe the utility of repetitive tDCS on motor function of patients with Parkinson's Disease. We aim to probe the effect of repetitive tDCS of dorsolateral prefrontal cortex and M1 cortex on motor function in patients with Parkinson's Disease (Hoehn and Yahr stage 2 to 4).
Interventions
- Device Transcranial Direct Current Stimulation
Anodal tDCS stimulation - Device Transcranial Direct Current Stimulation
Sham tDCS
Primary outcome measures
- To determine change in motor function score as assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part - III scale 1 week after the repetitive tDCS (Minimum Score 0, Maximum Score 132, higher scores indicate more disability) [Time frame: 1 week]
Secondary outcome measures (1)
- To determine the change in Timed Up and Go test score of patients with Parkinson's Disease at 1 week after the repetitive tDCS (higher times indicate disability with increased risk of fall) [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- Patients fulfilling the Movement Disorder Society (MDS) clinical diagnostic criteria for Parkinson's disease.
- Patients with Hoehn \& Yahr stages 2-4 Parkinson's disease.
- Patients maintained on stable medical regimen for at least 1 month before entering the study.
Exclusion criteria
- Patients with other confounding neurological and psychiatric disorders.
- The presence of metal objects or stimulators in the head.
- Patients with a history of deep brain stimulation.
- Patients with history of seizures.
- Patients with skull defect due to surgery e.g. craniectomy
- Patients with scalp condition likely to obstruct application of electrodes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
India · 1 center
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital — New Delhi
Identifiers
NCT: NCT07395531 · IEC/ABVIMS/RMLH/1092