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CTRI Number  CTRI/2020/03/024353 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 15/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Electrical Stimulation of tongue in Improving Hand Functions in Paraylzed Patients 
Scientific Title of Study   Effect of Periglossal Electrical Stimulation in Improving Hand Functions in Stroke Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayaprakash Jayavelu 
Designation  Chief Physiotherapist 
Affiliation  Narayana Superspeciality Hospital 
Address  Department of Physiotherapy and Rehabilitation Upper Basement, Narayana Superspeciality Hospital Plot No. 3201, Block V, DLF Phase III, Sector 24, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9899967907  
Fax    
Email  jjpm_2001@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jasobanta Sethi 
Designation  Director and Professor 
Affiliation  Amity University 
Address  Amity Institute of Physiotherapy F1, LG18, Amity University, Sector 125, Noida
Amity Institute of Physiotherapy F1,LG18 Amity University Sector 125, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone    
Fax    
Email  jsethi@amity.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Jasobanta Sethi 
Designation  Director and Professor 
Affiliation  Amity University 
Address  Amity Institute of Physiotherapy F1, LG 18 , Amity University Sector 125, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone    
Fax    
Email  jsethi@amity.edu  
 
Source of Monetary or Material Support  
Narayana Superspeciality Hospital, Plot 3201, Block - V, DLF Phase III, Sector 24, Gurugram Haryana 122001 
 
Primary Sponsor  
Name  Narayana Superspeciality Hospital 
Address  Plot 3201, Block-V, DLF Phase III, Sector 24, Gurugram 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jayaprakash  Narayana Superspeciality Hospital  Department of Physiotherapy, Upper Basement, Plot 3201, Block V, DLF PHASE III, SECTOR 24, Gurugram
Gurgaon
HARYANA 
9899967907

jjpm_2001@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Amity IEC  Approved 
DNSH IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I632||Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries, (2) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Stroke Rehabilitation  Conventional Stroke Rehabilitation 8 weeks duration 
Intervention  Tongue Stimulation along with conventional stroke rehabilitation  TOngue stimulation along with conventional stroke rehabilitation 8 weeks duration 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Stroke Patients with Hand Impairment 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugyl Meyer Upper Extremity Assessment scale
Action Research Arm Tesst 
Initial Assessment and 8 weeks post rehabilitation outcome 
 
Secondary Outcome  
Outcome  TimePoints 
EMG - Motor Unit Action Potential of Wrist Extensors  initial assessment and 8 weeks post rehab assessment 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2020 
Date of Study Completion (India) 10/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Jayaprakash Jayavelu, Jasobanta Sethi, Sahil Kohli, Tariq Matin. Effect of Electrical Stimulation of Tongue in Rehabilitation - A Systematic Review. Universal Journal of Stroke, Oct 2021, 9 (5), 253-262. 2. Jayaprakash Jayavelu, Jasobanta Sethi, Sahil Kohli, Sachin Gupta, Tariq Matin. Effect of Periglossal Electrical Stimulation on Haemodynamic Parameters in Stroke Patients – An Experimental Study. Journal of Clinical and Diagnostic Research, 2022, 16 (1), YC01-YC03. 3. Jayaprakash Jayavelu, Jasobanta Sethi, Sahil Kohli, Tariq Matin. Effect of Tongue Stimulation on Upper Extremity Recovery in Stroke Patients – A Randomized Controlled Trial. Universal Journal of Stroke, Feb 2022, 10(1), 25-33. DOI: 10.13189/ujph.2022.100103  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background and Gaps in Current Knowledge:

Stroke is one of the leading cause of mortality in developed and as well as in developing countries.20  The prevalence of stroke in India varies from 40 to 270 per 100000 population. The mortality and survival in stroke patients depend on various factors like demographic, comorbidity, severity and specific therapy.20

Longitudinal studies of recovery after stroke suggest that only 50% of the patients with significant arm paresis recover useful functions.12Severity of arm paresis in the first month after stroke remains the strongest predictor of the outcome.  Impact of initial severity can be lessened with the new rehabilitation techniques in the first 6 months after stroke.12

The study done by Kiwako Sakamoto et al indicates somatosensory-evoked magnetic fields in normal subjects after stimulation of the right and left antero-lateral margins of the tongue, and the right and left postero-lateral margins. MEG signals were detected from both hemispheres but the latency of all components was significantly shorter in the contralateral than ipsilateral hemisphere independent of the area stimulated. This clarified the brain responses of tongue SI using MEG.

Elliot J. Roth et al9 found that the tongue drive system is a safe and effective way to control wheelchairs, computers, and smartphones using tongue motion.

•      Tongue stimulation and neuroplasticity

Yoshihiro et al13 (2015) Repeated tongue lift movement can trigger neuroplasticity reflected in increased excitability of the corticomotor representation of not only the tongue muscles but also the masseter muscles

Gabriel Leonard et al (2017)14

•      Tongue can be used as an effective interface for conveying electrical signals to the CNS, including sensory substitution in balance impaired or blind people.

•      Noninvasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplastic changes in multiple sclerosis.

•      Significant blood oxygen level dependent signal changes in the left primary motor cortex.

Eliana et al 2016 15 - Tongue trills associated with transcutaneous electrical nerve stimulation improved in voice quality.

·         Frequency of 10 Hz, pulse of 250 microsec and intensity according to the comfort threshold of the patient

·         Procedure involved tongue trills with or without TENS for 3 minutest and repeating the technique for 2 minutes.

Ali Barikroo16 et al 2017

•      TENS improved swallowing

•      TENS – pulse rate of 80 Hz, pulse duration of 700 microsec.

•      Muscles stimulated participated in posterior tongue movement during swallowing.

Tongue Stimulation and Balance

•      Joseph C Wildenberg (2011)10 et al found that high-resolution fMRI detects neuromodulation of individual brainstem nuclei by electrical tongue stimulation in balance impaired individuals.  The pontine region is the trigeminal nucleus and that tongue stimulation interfaces with the balance-processing network within the pons 10

Tongue Stimulation and Stroke Patients

•      Mary Beth Badke18 et al found that electrotactile biofeedback seems to be promising integrative method in balance training.

Tongue Stimulation and Spinal Cord Injury

•      Chisholm et al (2014)19 found that sensory tongue stimulation combined with task specific therapy in people with spinal cord injury – a case study. 

•      2 Male SCI – combined balance exercises – standing with eyes closed 20 minutes and 30 minutes of body weight supported treadmill walking. Combined with Portable Neuromodulation Stimulation (PoNS) tongue  - 12 weeks

•      19 V, 200 Hz, Pulse Width – 0.4 to 60 microseconds.

Tongue Movements and Wrist Motion

•      Ghovanloo1 has done a project work on accelerating Upper Limb Rehabilitation in Stroke Patients by Engaging Synchronous Tongue and Wrist Motion.

•      The areas in the brain responsible for motor control of the tongue and the upper limbs will reorganize and remap intra-cortical pathways after an ischemic injury, establishing a new sensorimotor pathway for the paralyzed upper limb. 1

•      Therefore, stroke patients may receive additional long- lasting functional benefits, over the 12-week period of rehabilitation therapy as a result of neuroplasticity.1

 

Aim:

To find out the effect of periglossal electrical stimulation in improving hand functions in stroke patients

Objectives

•      To find out the effectiveness of periglossal electrical stimulation on hand functions in stroke patients.

•      To find out the effectiveness of  periglossal electrical stimulation on upper limb functions in stroke patients.

•      To find out the effectiveness of  periglossal electrical stimulation on motor unit action potential of wrist extensors in stroke patients.

Hypothesis

Null Hypothesis
1. There will be no significant effect of periglossal electrical stimulation on hand functions in stroke patients.

2. There will be no significant effect of periglossal electrical stimulation on upper limb functions in stroke patients.

3. There will be no significant effect of periglossal electrical stimulation on motor unit action potential of wrist extensors in stroke patients.

Experimental Hypothesis

1. There will be significant effect of periglossal electrical stimulation on hand functions in stroke patients.

2. There will be significant effect of periglossal electrical stimulation on upper limb functions in stroke patients.

3. There will be significant effect of periglossal electrical stimulation on motor unit action potential of wrist extensors in stroke patients.




Study Design:  Randomized Controlled Study

 Patients will be randomized into two groups by computerized randomization method

    Group 1 – Control Group

     Group II – Experimental Group

Study Type:  Experimental Study

Study Setting: Narayana Superspecialty Hospital, Gurugram

Selection Criteria for Sample:  Consecutive Convenient Sample

 Sample Size – 28 in each group (total – 56)

        

Inclusion Criteria

       All stroke patients with hand impairments will be included for the study

       Age group – 30 to 60

       GCS – E4M6V1 to E4M6V5

       Brunnstorm Stage II

Exclusion Criteria

       Unstable hemodynamics

       Any musculoskeletal deformity Involving upper limb

PARAMETER AND TOOL

       Arm functions – Action Research Arm Test

       Muscle Activity – EMG

       Arm Functions – Fugyl Meyer Test

Levels of Assessment

       At the time of enrolment in study

       After 8 weeks

       Methodology

Patients will undergo stimulation for 15 minutes along with wrist and hand motion – 5 days a week.

       Frequency – 20 Hz

       Pulse width – 200 microseconds

       Intensity according to tolerable threshold by the patients

       Patients will undergo regular stroke rehabilitation 60 minutes

       After 4 weeks and 8 weeks, parameters were assessed.


References

1.      Maysam Ghovanloo, PhD and Andrew Butler, PhD. Complete Project: Accelerating Upper Limb Rehabilitation in Stroke Patients by Engaging Synchronous Tongue and Wrist Motion Co-PIs:.  Georgia Institute of Technology, 2Georgia State University, 3VA Medical Center

2.      Nau A, Hertle RW, Yang D,; Effect of tongue stimulation on nystagmus eye movements in blind patients. Brain Struct Funct - July 1, 2012; 217 (3); 761-5

3.      Mohit Kotharia, PeterSvenssona, Jørgen Feldbæk Nielsen, Lene Baad-Hansen. Influence of position and stimulation parameters on intra cortical inhibition and facilitation in human tongue motor cortex. b r a i n r e s e a r c h 1 5 5 7 ( 2 0 1 4 ) 8 3 – 8 9

4.      Eung-Kwon Pae , Jon-Philippe K. Hyatt, Jennifer Wu, Patricia Chien.  Short-term electrical stimulation alters tongue muscle fibre type composition. a r chi v e s o f or a l b i o l ogy 52 ( 20 0 7 ) 5 4 4 – 5 5 1

5.      A. Szelenyi, E. Fava. Late tongue responses elicited by transcranial electric stimulation and peripheral median nerve stimulation.   Abstracts of Poster Presentations / Clinical Neurophysiology 125, Supplement 1 (2014) S1–S339

6.      Giulia Mascioli, Giovanni Berlucchi, Chiara Pierpaoli, Ugo Salvolini, Paolo Barbaresi, Mara Fabri, Gabriele Polonara. Functional MRI cortical activations from unilateral tactile-taste stimulations of the tongue. Physiology & Behavior 151 (2015) 221–229

7.      Kiwako Sakamoto, Hiroki Nakata, Masato Yumoto and Ryusuke Kakigi.  Somatosensory Processing of the Tongue in Humans. Frontiers in Physiology · November 2010

8. Kiwako Sakamotoa, Hiroki Nakataa, Ryusuke Kakigia.  Somatosensory-evoked magnetic fields following stimulation of the tongue in humans. Clinical Neurophysiology 119 (2008) 1664–1673

9. Elliot J. Roth, MD et al.  The Tongue Drive System: Testing Novel Assistive Technology that Uses Magnetic Signals Derived from Tongue Movements.

10. Joseph C. Wildenberg et al.  High-resolution fMRI detects neuromodulation of individual brainstem nuclei by electrical tongue stimulation in balance impaired individuals. Neuroimage. 2011 June 15; 56(4): 2129–2137.

11. Joseph C. Wildenberg et al . Sustained cortical and subcortical neuromodulation induced by electrical tongue stimulation. Brain Imaging Behav. 2010 December ; 4(3-4): 199–211

12. John W. Krakauer.  Arm Function After Stroke:  From Physiology to Recovery.  Seminars in Neurology/Vol 25, Nov 4

13. Yoshihiro Komoda et al.  Repeated tongue lift movement induces neuroplasticity in corticomotor control of tongue and jaw muscles in humans. Brain Research 1627, 2015, 70-79

14. Gabriel Leonard et al.  Noninvasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplastic changes in patients with multiple sclerosis; A multimodal neuroimaging study.  Multiple Sclerosis Journal – Experimental, Translational and Clinical. Jan- March 2017 1-9

15. Eliana Maria et al. Immediate effects of tongue trills associated with transcutaneous electrical nerve stimulation.  2016

16. Ali Barikroo.  Effect of transcutaneous electrical stimulation amplitude on timing of swallow pressure peaks between healthy young and older adults.  Gerondontology 2017. 34; 24-32.

17. Joseph C wildenberg et al.  Electrical tongue stimulation normalizes activity within the motion sensitive brain network in Balance impaired subjects as revealed by group independent component analysis.  Brain Connectivity. Vol 1. Number 3. 2011.

18. Mary Beth Badke et al. Tongue based biofeedback for balance in stroke. Arch Phys Med Rehabil Vol 92. Sept 2011.

19. Chisholm et al.  Feasability of sensory tongue stimulation combined with task specific therapy in people with spinal cord injury: a case study.  Neuroeng Rehabil – June 6, 2014; 11; 96

20. Priya Gupta, Kameshwar Prasad, Amit Kumar, Pradeep Kumar, Rohit Bhatia, Manjari Tripathi. Clinical Predictors and Outcome of Patients of acute stroke requiring ventilator support:  A prospective hospital based cohort study: Journal of Neurological Sciences 337 (2014) 14-17.


 
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