Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Parkinson's Disease

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDr. Ram Manohar Lohia Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Direct Current Stimulation

    Device

    Anodal tDCS stimulation

  • Transcranial Direct Current Stimulation

    Device

    Sham tDCS

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Anodal tDCS arm (will receive true tDCS)Experimental treatment 1 intervention
Group B: Sham tDCS arm (will receive Sham stimulation)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

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

Other outcomes

Sponsors and contacts

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