Anodal Transcranial Direct Current Stimulation and Cognition in Stroke

NCT05814588 | Completed DMC

• 1 other identifier: REC01356 Shaher Bano
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Fugl- Meyer Assessment Scale:

  18 week

• Functional Independence Measure

  18 week

Study Arms (2)

Group A

EXPERIMENTAL

Other: Anodal TDCS

Group B

SHAM COMPARATOR

Other: Anodal TDCS; Other: Sham Anodal TDCS

Interventions

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).

Group A; Group B

Sham Anodal TDCS OTHER

rehacom cognitive therapy will be provided to this group participants

Group B

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Alshifa hospital

Mandi Bahauddin, Punjab Province, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 33546266 BACKGROUND

• 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.

  PMID: 27372845 BACKGROUND

• 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.

  PMID: 33634831 BACKGROUND

• 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.

  PMID: 32186435 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mirza Obaid Baig, MSPT(NMR)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 18, 2023
• Study Start: April 2, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)