Nerve Transfers in Post-stroke Spasticity

NCT04437056 | Unknown

• 1 other identifier: EK 2319/2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is nowadays a leading cause of disability with devastating sequelae. Upper limb spasticity is one of them. Nevertheless, not all the muscles are equally affected, as some may turn spastic or paretic and other remain intact. This unique pathophysiological mosaic dictates a precise therapeutic plan. Existing spasticity treatment has significant drawbacks due to its unspecific targeting and short duration. A causal, life-lasting treatment, precisely adapted to every single patient's needs and to disease pattern, is currently missing. Hyperselective muscle denervation and subsequent cognitive reinnervation with appropriate unaffected donor nerves may break the pathological spastic circuit and provide volitional muscle control. With this pioneering study we will perform cognitive nerve transfers to spastic muscles and will prospectively investigate their effects on clinical, electrophysiological, molecular-biological and histological level. Accurate donor nerve selection will be for the first time quantified through motor unit number estimation with high-density needle electromyography. This revolutionary concept can open the window to a new era of therapeutic possibilities for stroke victims.

Conditions

Spasticity as Sequela of Stroke; Nerve Transfers

Outcome Measures

Primary Outcomes (3)

• Chedoke Arm and Hand Activity Inventory (CAHAI-9) score

  Patients can reach a score for CAHAI 9 between 9 to 63. The lower the score, the greater impairment.

  0-24 months

• Modified Ashworth Scale

  A score of 1 indicates no resistance, and 5 indicates rigidity. A 1+ scoring category indicates resistance through less than half of the movement. Scores range from 0-4, with 6 choices .

  0-24 months

• Changes in electrophysiological muscle activity after nerve transfers

  Low frequency-dependent depression of H-wave (in mV)

  0-24 months

Secondary Outcomes (6)

• Changes in muscle satellite cell population (%) in spastic muscles and comparison with healthy control group

  During surgery- 24 months

• The Action Research Arm Test (ARAT)

  0-24 months

• The Disabilities of the Arm, Shoulder and Hand (DASH) score

  0-24 months

• Motor Unit Number Estimation of donor and spastic muscles

  0-24 months

• Comparison of collagen content between spastic and healthy muscles

  During surgery- 12 months

Study Arms (1)

Stroke patients with upper limb spasticity

OTHER

Patients with post-stroke upper limb spasticity will be operated for cognitive nerve transfers to spastic muscles to allow for volitional muscle reinnervation and disrupture of spasticity. Adequate healthy nerve donors from the ipsilateral arm will be determined clinically and electrophysiologically.

Procedure: Cognitive nerve transfers to spastic upper extremity muscles in stroke patients

Interventions

Cognitive nerve transfers to spastic upper extremity muscles in stroke patients PROCEDURE

Based on the fact that upper motor neuron syndrome after stroke is presented with variable clinical features, usually without affecting in the same way the entire upper extremity, we aim to investigate the efficacy of nerve transfers to spastic muscles after stroke using as donor nerves that innervate unaffected ipsilateral volitionally controlled muscles.

Stroke patients with upper limb spasticity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are undergoing nerve transfers
• Age from 18 to 75 years old
• Minimum of 1 year interval after stroke
• Are able to understand German or English
• Medical Research Council (MRC) Muscle scale for donor nerves: M4 or M5
• Walking patients, with or without crutches
• Good general health condition and social support
• For the control group:
• Age 18-75 years old
• Indication for ulnar nerve release and submuscular transposition for compression neuropathy in the elbow
• No other neurological disorders

You may not qualify if:

• Stroke earlier than 3 years at the time of first consultation
• Lower limb spasticity and patients mobile with wheel chair

Sponsors & Collaborators

• Medical University of Vienna: lead
• Imperial College London: collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

General Hospital of Vienna

Vienna, 1090, Austria

Location

Related Publications (10)

• Urban PP, Wolf T, Uebele M, Marx JJ, Vogt T, Stoeter P, Bauermann T, Weibrich C, Vucurevic GD, Schneider A, Wissel J. Occurence and clinical predictors of spasticity after ischemic stroke. Stroke. 2010 Sep;41(9):2016-20. doi: 10.1161/STROKEAHA.110.581991. Epub 2010 Aug 12.

  PMID: 20705930 BACKGROUND

• Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.

  PMID: 23319481 BACKGROUND

• Sommerfeld DK, Gripenstedt U, Welmer AK. Spasticity after stroke: an overview of prevalence, test instruments, and treatments. Am J Phys Med Rehabil. 2012 Sep;91(9):814-20. doi: 10.1097/PHM.0b013e31825f13a3.

  PMID: 22760104 BACKGROUND

• Zheng MX, Hua XY, Feng JT, Li T, Lu YC, Shen YD, Cao XH, Zhao NQ, Lyu JY, Xu JG, Gu YD, Xu WD. Trial of Contralateral Seventh Cervical Nerve Transfer for Spastic Arm Paralysis. N Engl J Med. 2018 Jan 4;378(1):22-34. doi: 10.1056/NEJMoa1615208. Epub 2017 Dec 20.

  PMID: 29262271 BACKGROUND

• Qiu YQ, Du MX, Yu BF, Jiang S, Feng JT, Shen YD, Xu WD. Contralateral Lumbar to Sacral Nerve Rerouting for Hemiplegic Patients After Stroke: A Clinical Pilot Study. World Neurosurg. 2019 Jan;121:12-18. doi: 10.1016/j.wneu.2018.09.118. Epub 2018 Sep 26.

  PMID: 30266703 BACKGROUND

• Khalifeh JM, Dibble CF, Van Voorhis A, Doering M, Boyer MI, Mahan MA, Wilson TJ, Midha R, Yang LJS, Ray WZ. Nerve transfers in the upper extremity following cervical spinal cord injury. Part 1: Systematic review of the literature. J Neurosurg Spine. 2019 Jul 12;31(5):629-640. doi: 10.3171/2019.4.SPINE19173. Print 2019 Nov 1.

  PMID: 31299644 BACKGROUND

• Faturi FM, Lopes Santos G, Ocamoto GN, Russo TL. Structural muscular adaptations in upper limb after stroke: a systematic review. Top Stroke Rehabil. 2019 Jan;26(1):73-79. doi: 10.1080/10749357.2018.1517511. Epub 2018 Sep 17.

  PMID: 30222075 BACKGROUND

• Smith LR, Pichika R, Meza RC, Gillies AR, Baliki MN, Chambers HG, Lieber RL. Contribution of extracellular matrix components to the stiffness of skeletal muscle contractures in patients with cerebral palsy. Connect Tissue Res. 2021 May;62(3):287-298. doi: 10.1080/03008207.2019.1694011. Epub 2019 Nov 28.

  PMID: 31779492 BACKGROUND

• Mandeville RM, Brown JM, Sheean GL. Semi-quantitative electromyography as a predictor of nerve transfer outcome. Clin Neurophysiol. 2019 May;130(5):701-706. doi: 10.1016/j.clinph.2019.02.008. Epub 2019 Feb 28.

  PMID: 30875537 BACKGROUND

• Barreca S, Gowland CK, Stratford P, Huijbregts M, Griffiths J, Torresin W, Dunkley M, Miller P, Masters L. Development of the Chedoke Arm and Hand Activity Inventory: theoretical constructs, item generation, and selection. Top Stroke Rehabil. 2004 Fall;11(4):31-42. doi: 10.1310/JU8P-UVK6-68VW-CF3W.

  PMID: 15592988 BACKGROUND

Study Officials

• Oskar Aszmann, Prof

  Department of Surgery, Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, PhD Student Clinical Laboratory for Bionic Extremity Reconstruction

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 18, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)