Therapeutic Effect of Multi-Channel Transcranial Direct Current Stimulation (M-tDCS) on Recovery of Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors-A Randomized Controlled Trial Protocol

Midha Divya, Arumugam Narkeesh, Midha Divya, Arumugam Narkeesh

Abstract

Background: There has been rapid drift of rehabilitation professionals toward the clinical use of technology aided electrical interventions. Brain is a cortical hub of functionally related neural connections. Motor learning entails strong interaction with the cognitive domains. So better outcomes may be expected by optimally targeting functionally correlated areas simultaneously through tDCS.

Aim: To determine the therapeutic effect of Multi Channel tDCS in combination with Functional electrical stimulation, SaeboFlex and conventional rehabilitation on recovery of Cognitive Domains, Motor Functions of Paretic Hand, and Gait in individuals with subacute Stroke.

Methods: This is prospective, randomized, double blind controlled clinical trial. Subacute Stroke Survivors with the age Group (40-75 years) will constitute the Population of the study. Participants will be randomly allocated to experimental or control group. Participants of Experimental group will receive Multi channel tDCS, Functional electrical stimulation, Saebo Flex Training and conventional rehabilitation. Participants of the group B will receive FES, training with SaeboFlex, conventional physiotherapy intervention similar to as given to the participants of group A and sham multi channel tDCS.

Outcome measures: The primary outcome measures of the study will be Fugl Meyer assessment, Electroencephalogram and secondary outcome measures of the study will be Grip strength, Pinch strength, Nine hole peg test( NHPT), Wisconsin gait scale, Montreal cognitive assessment, Electroencephaloraphy to observe the cortical changes and tDCS adverse effect questionnaire and stroke specific quality of Life scale.

Statistical analysis: The primary analysis of the study will be done at the end of 4 weeks. Statistical analysis of data will be done using SPSS Version 22 with the help of a statistician.

Conclusion: An insight into the therapeutic interventions augmenting, cognitive and motor domains simultaneously may yield better outcomes in the field of stroke rehabilitation thereby improving quality of life of stroke survivors.

Keywords: Stroke; brain stimulation; multichannel transcranial direct current stimulation; stroke rehabilitation.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

© The Author(s) 2022.

Figures

Figure 1.
Figure 1.
The schematic Consolidated Standards of Reporting Trials flow chart for the study protocol. M-tDCS Multichannel Transcranial Direct Current Simulation, muscle; s-M-tDCS, Sham Multichannel Transcranial Direct Current Simulation.
Figure 2.
Figure 2.
Standard Protocol Items: Recommendations for Interventional Trials schedule for patient participation.
Figure 3.
Figure 3.
Anatomical Landmarks: (1): Nasion; (2): Inion; (3): A1-Right Pre Auricular Point; (4): A2-Left Pre Auricular Point.
Figure 4.
Figure 4.
Location of Primary Motor Cortex and Dorsolateral Prefrontal cortex via 10 to 20 EEG Classification System. PMC: [l];-Measure Distance between (Nz) & (Tz); [2]:-Locate (Cz) at the Midpoint between (Nz & Iz); [3]:- Locate (T3) & (T4) at 10%up from(Al) & (A2); [4]: Locate Points for (L-PMC) at(C3) at Midpoint of distance between (T3 & Cz) and (R-PMC) (C4) at Midpoint between (T4 & Cz). DLPFC: [5]: -Locate (Fpz) at 10% of the distance between (Nz) & (Oz) at 10% up from from (Iz); [6]:-Measure Distance between (Fpz) & (Oz); [7];-Locate (Fpl) & (Fp2) at 5% of total circumference of the head across (Fpz- Oz) and (O1) & (O2) at 5% of total circumference of the back of the head across (Fpz- Oz): [8]:-Locate a point at 10% distance from (Fpl) toward left ear as (F7) and at 10% distance from (Fp2) toward right ear as (F8);[9]:- Locate (Fz) at midpoint between (Fpz & Cz). further locate (L-DLPFC), that is, (F3) & (R-DLPFC), that is, (F4) at midpoint of (F7 & Fz) & (F8& Fz) respectively. (Nz):- Nasion, (Iz);- Inion, (F)-Frontal, (C):-Central, (O):- Occipital,(PMC):- Primary Motor Cortex, (L-PMC)-Left Primary Motor Cortex, (R-PMC): Right Primary motor cortex, (DLPFC)- Dorsolateral Prefrontal cortex, (L-DLPFC):-Left Dorsolateral Prefrontal Cortex, (R-DLPFC):- Right Dorsolateral Prefrontal cortex.
Figure 5.
Figure 5.
Conventional rehabilitation protocol. Adopted from Alon G. Levitt AF. Mccarthy PA, Functional Electrical Stimulation Enhancement of Upper Extremity Functional Recovery During. Stroke Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2007;21(3):207-15. Abbreviations: ADL, activities of daily living. ROM, range of motion. *Subject to vary as per individual’s rehabilitation need.

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