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

NCT07395531 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IEC/ABVIMS/RMLH/1092
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

PARKINSON DISEASE (Disorder); Parkinson Disease

Keywords

tDCS; Parkinson's Disease; Transcranial Direct Current Stimulation

Outcome Measures

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)

  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)

  1 week

Study Arms (2)

Anodal tDCS arm (will receive true tDCS)

EXPERIMENTAL

Will receive true anodal tDCS stimulation

Device: Transcranial Direct Current Stimulation

Sham tDCS arm (will receive Sham stimulation)

SHAM COMPARATOR

Will not receive anodal tDCS stimulation

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Anodal tDCS stimulation

Also known as: tDCS

Anodal tDCS arm (will receive true tDCS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Ram Manohar Lohia Hospital: lead

Study Sites (1)

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital

New Delhi, 110001, India

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ashish Kumar Duggal, DM (Neurology)

  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Kumar Duggal, Doctor (Professor)

CONTACT

+919810523332; ashishduggal2005@gmail.com

Devavrata Sahu, Doctor

CONTACT

+918800815928; devsahu.90@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology, ABVIMS and Dr RML Hospital, New Delhi

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: February 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

IN (1)