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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. Ram Manohar Lohia Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Direct Current Stimulation

    Device

    Anodal tDCS

  • Transcranial Direct Current Stimulation

    Device

    Sham tDCS

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Anodal tDCS arm (will receive true tDCS)Experimental treatment 1 intervention
Group B: Sham tDCS arm (will receive Sham stimulation)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at 5 days after tDCS
2

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.

Time frame
at 5 days after tDCS

Secondary outcomes

1

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.

Time frame
at 5 days after tDCS
2

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

Time frame
at 5 days after tDCS
3

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

Time frame
at 4 weeks after tDCS
4

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

Reaction times were documented in milliseconds.

Time frame
at 4 weeks after tDCS

Other outcomes

Sponsors and contacts

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