Anodal Transcranial Direct Current Stimulation and Cognition in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05814588
• Other study ID #: REC01356 Shaher Bano
• Status: Completed
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Pakistan	Alshifa hospital	Mandi Bahauddin	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 week
Primary	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	18 week
Secondary	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	18 week
Secondary	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	18 week