- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395531
Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Parkinson's Disease
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ashish Kumar Duggal, Doctor (Professor)
- Phone Number: +919810523332
- Email: ashishduggal2005@gmail.com
Study Contact Backup
- Name: Devavrata Sahu, Doctor
- Phone Number: +918800815928
- Email: devsahu.90@gmail.com
Study Locations
-
-
-
New Delhi, India, 110001
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
-
Contact:
- Ashish Kumar Duggal, Doctor (Professor)
- Phone Number: +919810523332
- Email: ashishduggal2005@gmail.com
-
Contact:
- Devavrata Sahu, Doctor
- Phone Number: +918800815928
- Email: devsahu.90@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anodal tDCS arm (will receive true tDCS)
Will receive true anodal tDCS stimulation
|
Anodal tDCS stimulation
Other Names:
Sham tDCS
Other Names:
|
|
Sham Comparator: Sham tDCS arm (will receive Sham stimulation)
Will not receive anodal tDCS stimulation
|
Anodal tDCS stimulation
Other Names:
Sham tDCS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashish Kumar Duggal, DM (Neurology), Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- IEC/ABVIMS/RMLH/1092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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