Menu
Not yet recruiting NCT07496645

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

Phase III Interventional Acute Ischemic Cerebrovascular Disease Post Stroke Aphasia Aphasia Following Cerebral Infarction Aphasia, Acquired

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Direct Current Stimulation, Transcranial Direct Current Stimulation.
Who it may be relevant to
Registry conditions: Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia, Aphasia Following Cerebral Infarction, Aphasia, Acquired. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Transcranial Direct Current Stimulation
    Anodal tDCS
  • Device Transcranial Direct Current Stimulation
    Sham tDCS

Primary outcome measures

  • Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days [Time frame: 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 [Time frame: at 5 days after tDCS]
Secondary outcome measures (6)
  • Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days [Time frame: at 5 days after tDCS]
  • Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days [Time frame: at 5 days after tDCS]
  • Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks [Time frame: at 4 weeks after tDCS]
  • Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks [Time frame: at 4 weeks after tDCS]
  • Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks [Time frame: at 4 weeks after tDCS]
  • Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks [Time frame: at 4 weeks after tDCS]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Health services research

Study locations

India · 1 center
  • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New — New Delhi

Identifiers

NCT: NCT07496645 · IEC/ABVIMS/RMLH/1093

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗