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StrokeNCT05814588

Anodal Transcranial Direct Current Stimulation and Cognition in Stroke

A study testing Anodal TDCS in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
Anodal TDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 sitePakistan
Study dates
2 Apr 2023to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Alshifa hospital

    Mandi Bahauddin, Punjab Province

Other trials in Pakistan

About this study

Official title: 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.

Read the 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)

Conditions
Stroke
Being tested
Anodal TDCS, Sham Anodal TDCS
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anodal TDCSOther

    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 TDCSOther

    rehacom cognitive therapy will be provided to this group participants

Study groups in NCT05814588
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Other: Anodal TDCS
Group BSham comparatorNot described
Receives: Other: Anodal TDCS; Other: Sham Anodal TDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RehaCom Software

    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

    Measured: 18 week

  2. Montreal Cognitive Assessment Scale

    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

    Measured: 18 week

Secondary outcomes (2)

  1. Fugl- Meyer Assessment Scale:

    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

    Measured: 18 week

  2. Functional Independence Measure

    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

    Measured: 18 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start2 Apr 2023
  3. Primary completion31 Oct 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05814588
Sponsor's protocol ID
REC01356 Shaher Bano
Status last verified
Dec 2023
First submitted
23 Feb 2023
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hara T, Shanmugalingam A, McIntyre A, Burhan AM. The Effect of Non-Invasive Brain Stimulation (NIBS) on Attention and Memory Function in Stroke Rehabilitation Patients: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2021 Feb 3;11(2):227. doi: 10.3390/diagnostics11020227.

    PubMed 33546266

  • Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

    PubMed 27372845

  • Liu YW, Chen ZH, Luo J, Yin MY, Li LL, Yang YD, Zheng HQ, Liang ZH, Hu XQ. Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. J Rehabil Med. 2021 Mar 9;53(3):jrm00162. doi: 10.2340/16501977-2807.

    PubMed 33634831

  • Cirillo J, Mooney RA, Ackerley SJ, Barber PA, Borges VM, Clarkson AN, Mangold C, Ren A, Smith MC, Stinear CM, Byblow WD. Neurochemical balance and inhibition at the subacute stage after stroke. J Neurophysiol. 2020 May 1;123(5):1775-1790. doi: 10.1152/jn.00561.2019. Epub 2020 Mar 18.

    PubMed 32186435

Questions about this trial

What is this clinical trial studying?

A study testing Anodal TDCS in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RehaCom Software (time frame: 18 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05814588, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

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