Anodal Transcranial Direct Current Stimulation and Cognition in Stroke

December 19, 2023 updated by: Riphah International University

Effects of Anodal Transcranial Direct Current Stimulation on Cognition in Subacute Stroke

Pervious literature shows the effects of tDCS and RehaCom on cognition in chronic stage of stroke and only short-term effects were seen, but detailed evidence-based study on cognition in subacute and acute stages of stroke is spare and there is limited number of studies are available on effects of tDCS in cognition in both acute and subacute stages of stroke. Some polite studies were done in acute stage of stroke and only short-term effects of tDCS were evaluated along with other outcome measures including upper and lower limb motor recovery, balance and improving activity of daily living. The long-term effects of transcranial direct stimulation only for the improvement of cognition in subacute stage of stroke are yet to be seen. This study will help us in evaluating the long-term effects of aTDCS and RehaCom cognitive therapy on cognition in subacute stage of stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous literature showed that, the brain has a capacity to recover the loss that comes after brain damage within subacute stage, as in this stage there is high excitation-inhibition phenomena in neural circuit, this excitation-inhibition spectacles may reflect to upsurge the activity of neurotransmitter concentration within cortex that put subtle effect for developing neural plasticity.

More innovative therapies are used worldwide in patient's cognitive rehabilitation after stroke, for cognitive training including physical movement, paper-and-pencil activities, manipulatives training programs or other aids such as playing cards or a combination of multiple training, along with transcranial direct current stimulation (tDCS) and RehaCom cognitive therapy which shows significant effects with (p < 0.05) in acute and chronic stages of stroke. Most of the studies used a different type of therapy in therapeutic protocols for other functional improvement including motor recovery exercises for both upper and lower limb balance training, postural stability exercises, manipulative training programs with significant improvement (p < 0.05) in real time (tDCS)

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Mandi Bahauddin, Punjab, Pakistan
        • Alshifa hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First ischemic stroke of frontal cortex
  • Subacute stroke
  • Age 40-60 years of both genders
  • Individual with 10 years formal education
  • MMSE score between 19 and 24
  • MoCA score is minimum10
  • FIM score between 84 and 99
  • Beck depression inventory ranged between 0 and 10

Exclusion Criteria:

  • Hearing and Visual loss/ deficit
  • Recurrent CVA
  • Neurological condition affects the cognition
  • Receiving the drugs affect the cognition like anti-depressant, anti-epileptics etc
  • Wound at skull
  • Presence of shunt
  • Brain tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Other: Anodal TDCS

RehaCom software is a computer assisted cognitive rehabilitation, it targets six programs of brain including attention, memory, and higher executive function, visuo-motor abilities, visual filed, vocational abilities, each module is divided into further subsections there is 36 total subsections, we will work on 6 subsections in every week.

The aTDCS device is a battery operated, with a pair of rubber conductive electrodes (size 7×5cm) enclosed with sponge saturated pockets (pads).
Sham Comparator: Group B
Other: Anodal TDCS

RehaCom software is a computer assisted cognitive rehabilitation, it targets six programs of brain including attention, memory, and higher executive function, visuo-motor abilities, visual filed, vocational abilities, each module is divided into further subsections there is 36 total subsections, we will work on 6 subsections in every week.

The aTDCS device is a battery operated, with a pair of rubber conductive electrodes (size 7×5cm) enclosed with sponge saturated pockets (pads).

Other: Sham Anodal TDCS
rehacom cognitive therapy will be provided to this group participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RehaCom Software
Time Frame: 18 week
RehaCom is a software package that is used for the assessment of cognitive functions. RehaCom is operated with computer. There are 9 different modules for screening including, Alertness, Campimetry, Divided attention, Logical reasoning, Memory for words, Selective attention, Spatial numbers search, Visual field, working Memory. There are following parameters that will assessed in each module, Level changes (duration of session, level up 95%, and level down 70%), stimulus condition and how many mistakes done, maximum react time and repetition of each task etc. parameters which will assessed are mentions. Changes will be recorded at 0, 6, 12 & 18 week
18 week
Montreal Cognitive Assessment Scale
Time Frame: 18 week
a brief instrument for screening the cognitive impairment in stroke. It is a 30-question test that takes around 10 to 12 minutes to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal. Changes will be recorded at 0, 6, 12 & 18 week
18 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl- Meyer Assessment Scale:
Time Frame: 18 week
It is a Primary tool for evaluation of motor recovery for post-stroke motor impairments. It is an ordinal scale that has 3 points for each item. Changes will be recorded at 0, 6, 12 & 18 week
18 week
Functional Independence Measure
Time Frame: 18 week
Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. The FIM comprises 18 items: 13 define disabilities in motor functions, and 5 define disabilities in cognitive functions. FIM scores range from 1 to 7 (1 = total assist and 7 = complete independence). Changes will be recorded at 0, 6, 12 & 18 week
18 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC01356 Shaher Bano

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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