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临床试验/CTRI/2020/03/024353
CTRI/2020/03/024353已完成不适用

Effect of Periglossal Electrical Stimulation in Improving Hand Functions in Stroke Patients

Narayana Superspeciality Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Fugyl Meyer Upper Extremity Assessment scale

研究概览

简要总结

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.

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

  2. 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

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

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

  3. 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.

  4. 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

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

  6. 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

  7. 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

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

  9. 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.

  10. 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.

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

  12. 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

  13. 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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • •Stroke Patients with Hand Impairment.

排除标准

  • 未提供

结局指标

主要结局

Fugyl Meyer Upper Extremity Assessment scale

时间窗: Initial Assessment and 8 weeks post rehabilitation outcome

Action Research Arm Tesst

时间窗: Initial Assessment and 8 weeks post rehabilitation outcome

次要结局

  • EMG - Motor Unit Action Potential of Wrist Extensors(initial assessment and 8 weeks post rehab assessment)

研究者

发起方
Narayana Superspeciality Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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