Clinical trial NCT05814588: Anodal Transcranial Direct Current Stimulation and Cognition in Stroke
Official title: Effects of Anodal Transcranial Direct Current Stimulation on Cognition in Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: RehaCom Software
timeFrame: 18 week
measure: Montreal Cognitive Assessment Scale
timeFrame: 18 week
Secondary outcomes:
measure: Fugl- Meyer Assessment Scale:
timeFrame: 18 week
measure: Functional Independence Measure
timeFrame: 18 week
Other outcomes:
Locations:
city: Mandi Bahauddin
country: Pakistan
facility: Alshifa hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT(NMR)
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.