EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE

The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other.

In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging.

Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.

Study Overview

• Status: Not yet recruiting
• Conditions: Aphasia, Acquired; Aphasia Following Cerebral Infarction; Post Stroke Aphasia; Acute Ischemic Cerebrovascular Disease
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation; Device: Transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 28
• 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

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110001
      • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
      • Contact: Devavrata Sahu, Doctor; Phone Number: +918800815928; Email: devsahu.90@gmail.com
      • Contact: Devavrata Kumar Duggal, Doctor (Professor); Phone Number: 08800815928; Email: devsahu.90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aphasic patients with left middle cerebral artery territory Acute Ischemic Stroke
• Patients between 18-65 years of age.
• Within 5 days of onset of stroke.

Exclusion Criteria:

• Patients with malignant Middle Cerebral Artery territory infarcts and previous clinical history of cerebral hemisphere stroke.
• Patients with history of previous brain surgery or skull defect due to surgery e.g. craniectomy.
• Patients with epilepsy.
• Patients with history of significant head trauma in the last 1 month.
• Patients with documented history of major depression prior to stroke.
• Patients with alcohol/drug abuse in the past 6 months.
• Patients with prior significant cognitive impairment.
• Pacemaker in situ, cochlear implant in situ.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal tDCS arm (will receive true tDCS); Will receive true Anodal tDCS	Device: Transcranial Direct Current Stimulation; Sham tDCS; Device: Transcranial Direct Current Stimulation; Anodal tDCS
Sham Comparator: Sham tDCS arm (will receive Sham stimulation); Will receive Sham tDCS stimulation	Device: Transcranial Direct Current Stimulation; Sham tDCS; Device: Transcranial Direct Current Stimulation; Anodal tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days	Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test	at 5 days after tDCS
Co-Primary outcome: Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 5 days	Reaction times were documented in milliseconds.	at 5 days after tDCS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days	Correct Response is defined as the total number of words spoken, with or without the help of either a semantic or a phonemic cue on the ICMR Picture Naming Test.	at 5 days after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days	PNT scores are recorded as per the guidelines of the ICMR Picture Naming Test	at 5 days after tDCS
Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks	Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test	at 4 weeks after tDCS
Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks	Reaction times were documented in milliseconds.	at 4 weeks after tDCS
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks	Correct Response is defined as the total number of words spoken, with or without the help of either a semantic or a phonemic cue on the ICMR Picture Naming Test.	at 4 weeks after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks	PNT scores are recorded as per the guidelines of the ICMR Picture Naming Test.	at 4 weeks after tDCS

Collaborators and Investigators

• Sponsor: Dr. Ram Manohar Lohia Hospital
• 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): March 31, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: tDCS; Transcranial Direct Current Stimulation; Post stroke aphasia; Acute Ischemic Cerebrovascular Disease; Aphasia Following Cerebral Infarction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Aphasia; 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/1093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No