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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06209801
Other study ID # 202301500A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2027

Study information

Verified date January 2024
Source Chang Gung Memorial Hospital
Contact Yueh-Hsia Chen, PhD
Phone +886-3366-8133
Email yuehhsiachen@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Peripheral nerve injury is common and can result in loss of sensation and motor function, reduced quality of life, and prolonged time to return to work. Maladaptive cortical reorganization occurs after nerve injury or immobilization and can further impair the recovery process. To improve the sensorimotor prognosis of people with peripheral nerve injury, methods such as mirror therapy, motor imagery, and electrical stimulation have been used in addition to usual care. However, no studies have shown the effect of integrating mirror therapy, motor imagery, and electrical stimulation in these individuals. Furthermore, the real-time effect of mirror therapy on cortical activation in this population remains unexplored. This study aims to determine the real-time cortical modulation effects of mirror therapy combined with electrical stimulation in individuals with peripheral nerve injury.


Description:

Two groups of subjects (a group of peripheral nerve injury group and a group of healthy adults) will perform hand exercises in three randomized conditions: (1) mirror therapy with electrical stimulation and motor imagery, (2) electrical stimulation and motor imagery, and (3) motor imagery. Each participant performs specific sets of two exercises based on the type of nerve injury: (1) Median nerve injury: Picking up and putting down a pen using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger. (2) Ulnar nerve injury: Picking up and putting down a card using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger.(3) Brachial plexus injury: Picking up and putting down an empty cup, and picking up and putting down a pair of pliers. For combined median nerve and ulnar nerve injuries and healthy adult groups, movements corresponding to median nerve injuries are performed. Each experimental condition consists of 20 repetitions, lasting 60 seconds, followed by a 30-second rest between conditions. Relative alpha and beta band power in the sensorimotor cortex will be recorded and analyzed.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 31, 2027
Est. primary completion date November 21, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - newly diagnosed median or ulnar nerve transection injury of the forearm in the past 6 months - sufficient communication in the Chinese language - being able to follow instructions - muscle atrophy or lack of voluntary contraction over the injured hand, with maximum voluntary isometric contraction (MVIC) recorded with surface electromyography (EMG) less than 10% compared to the non-affected hand - achieve an average score of 2 or above in the Kinesthetic and Visual Imagery Questionnaire-10 (KVIQ-10) for kinesthetic imagery Exclusion Criteria: - had central nervous disease - had a recent (1 year) history of nerve entrapment syndrome - had a history of latent neuropathy, such as diabetes or dialysis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mirror therapy
60 seconds of intervention
Device:
Neuromuscular electrical stimulation
60 seconds of intervention
Behavioral:
Motor imagery
60 seconds of intervention

Locations

Country Name City State
Taiwan National Taiwain Univeristy, Colledge of Medicine, School and Graduate Institude of Physicl Therapy Taipei
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital National Taiwan University

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

Bello UM, Kranz GS, Winser SJ, Chan CCH. Neural Processes Underlying Mirror-Induced Visual Illusion: An Activation Likelihood Estimation Meta-Analysis. Front Hum Neurosci. 2020 Jul 31;14:276. doi: 10.3389/fnhum.2020.00276. eCollection 2020. — View Citation

Bello UM, Winser SJ, Chan CCH. Role of kinaesthetic motor imagery in mirror-induced visual illusion as intervention in post-stroke rehabilitation. Rev Neurosci. 2020 Aug 27;31(6):659-674. doi: 10.1515/revneuro-2019-0106. — View Citation

Binder E, Dovern A, Hesse MD, Ebke M, Karbe H, Saliger J, Fink GR, Weiss PH. Lesion evidence for a human mirror neuron system. Cortex. 2017 May;90:125-137. doi: 10.1016/j.cortex.2017.02.008. Epub 2017 Feb 24. — View Citation

Cengiz B, Vuralli D, Zinnuroglu M, Bayer G, Golmohammadzadeh H, Gunendi Z, Turgut AE, Irfanoglu B, Arikan KB. Analysis of mirror neuron system activation during action observation alone and action observation with motor imagery tasks. Exp Brain Res. 2018 Feb;236(2):497-503. doi: 10.1007/s00221-017-5147-5. Epub 2017 Dec 11. — View Citation

Chen YH, Siow TY, Wang JY, Lin SY, Chao YH. Greater Cortical Activation and Motor Recovery Following Mirror Therapy Immediately after Peripheral Nerve Repair of the Forearm. Neuroscience. 2022 Jan 15;481:123-133. doi: 10.1016/j.neuroscience.2021.11.048. Epub 2021 Dec 5. — View Citation

Lu Y, Liu H, Hua X, Xu JG, Gu YD, Shen Y. Attenuation of brain grey matter volume in brachial plexus injury patients. Neurol Sci. 2016 Jan;37(1):51-56. doi: 10.1007/s10072-015-2356-1. Epub 2015 Aug 9. — View Citation

Rizzo M, Petrini L, Del Percio C, Lopez S, Arendt-Nielsen L, Babiloni C. Mirror visual feedback during unilateral finger movements is related to the desynchronization of cortical electroencephalographic somatomotor alpha rhythms. Psychophysiology. 2022 Dec;59(12):e14116. doi: 10.1111/psyp.14116. Epub 2022 Jun 3. — View Citation

Saavedra-Garcia A, Moral-Munoz JA, Lucena-Anton D. Mirror therapy simultaneously combined with electrical stimulation for upper limb motor function recovery after stroke: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2021 Jan;35(1):39-50. doi: 10.1177/0269215520951935. Epub 2020 Aug 24. — View Citation

Scott M, Taylor S, Chesterton P, Vogt S, Eaves DL. Motor imagery during action observation increases eccentric hamstring force: an acute non-physical intervention. Disabil Rehabil. 2018 Jun;40(12):1443-1451. doi: 10.1080/09638288.2017.1300333. Epub 2017 Mar 21. — View Citation

Wang J, Fritzsch C, Bernarding J, Holtze S, Mauritz KH, Brunetti M, Dohle C. A comparison of neural mechanisms in mirror therapy and movement observation therapy. J Rehabil Med. 2013 Apr;45(4):410-3. doi: 10.2340/16501977-1127. — View Citation

Yang YJ, Jeon EJ, Kim JS, Chung CK. Characterization of kinesthetic motor imagery compared with visual motor imageries. Sci Rep. 2021 Feb 12;11(1):3751. doi: 10.1038/s41598-021-82241-0. — View Citation

Zhang JJQ, Fong KNK, Welage N, Liu KPY. The Activation of the Mirror Neuron System during Action Observation and Action Execution with Mirror Visual Feedback in Stroke: A Systematic Review. Neural Plast. 2018 Apr 24;2018:2321045. doi: 10.1155/2018/2321045. eCollection 2018. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Relative alpha-band power in sensorimotor cortex Expressed as a percentage 10 minutes after the intervention
Primary Relative beta-band power in sensorimotor cortex Expressed as a percentage 10 minutes after the intervention
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