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

NCT07496645 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IEC/ABVIMS/RMLH/1093
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Cerebrovascular Disease; Post Stroke Aphasia; Aphasia Following Cerebral Infarction; Aphasia, Acquired

Keywords

Transcranial Direct Current Stimulation; tDCS; Acute Ischemic Cerebrovascular Disease; Post stroke aphasia; Aphasia Following Cerebral Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days

  at 5 days after tDCS

• Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days

  at 5 days after tDCS

• Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks

  at 4 weeks after tDCS

• Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks

  at 4 weeks after tDCS

• Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks

  at 4 weeks after tDCS

Study Arms (2)

Anodal tDCS arm (will receive true tDCS)

EXPERIMENTAL

Will receive true Anodal tDCS

Device: Transcranial Direct Current Stimulation

Sham tDCS arm (will receive Sham stimulation)

SHAM COMPARATOR

Will receive Sham tDCS stimulation

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Anodal tDCS

Anodal tDCS arm (will receive true tDCS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Aphasia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: March 21, 2026
• First Posted: March 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

IN (1)