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NCT Number: NCT05814588

Anodal Transcranial Direct Current Stimulation and Cognition in 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alshifa hospital

Mandi Bahauddin, Punjab Province, Pakistan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Other

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 Anodal TDCS

Other

rehacom cognitive therapy will be provided to this group participants

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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