NCT04217187

Brief Summary

The purpose of this study is to investigate the effectiveness of using electrical stimulation to improve upper extremity function in stroke survivors who receive botulinum toxin injections for spasticity. We hypothesize that individuals who receive the electrical stimulation could demonstrate improved benefit of the botulinum toxin injections and improved functional use of their weaker upper extremity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 2, 2020

Last Update Submit

January 3, 2020

Conditions

Stroke

Keywords

Botulinum ToxinsSpasticityUpper ExtremityElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage

    Impairment level assessment to measure changes in active motor control and isolated movement in the upper extremity. The arm and the hand receive a separate score. The score ranges from 1 to 7. A higher score indicates better arm function.

    Baseline, 1 month and 6 months after injections

Secondary Outcomes (5)

  • Action Research Arm Test

    Baseline, 1 month and 6 months

  • Box and Block Test

    Baseline, 1 month and 6 months after injections

  • Motor Activity Log

    Baseline, 1 month and 6 months after injections

  • Modified Ashworth Scale for the Upper Extremity

    Baseline, 1 month and 6 months

  • Numeric Pain Rating Scale

    Baseline, 1 month and 6 months

Study Arms (2)

Electrical Stimulation Group

EXPERIMENTAL

This arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity.

Device: Neuromuscular Electrical Stimulation

Sham Stimulation Group

SHAM COMPARATOR

This arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity.

Device: Sham Electrical Stimulation

Interventions

Neuromuscular Electrical StimulationDEVICE

Upper extremity neuromuscular electrical stimulation

Electrical Stimulation Group
Sham Electrical StimulationDEVICE

Sensory only upper extremity electrical stimulation

Sham Stimulation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stroke, within first 6 months post stroke, have not previously received botulinum toxin injections for upper extremity spasticity, hemiplegic upper extremtity, able to communicate in English.

You may not qualify if:

  • contraindication for electrical stimulation (presence of implanted cardiac or other medical device, open wound on the wrist or hand, malignancy), fixed contracture of the elbow, wrist or hand, inability to follow simple directions, pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (12)

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND

  • Bejot Y, Daubail B, Giroud M. Epidemiology of stroke and transient ischemic attacks: Current knowledge and perspectives. Rev Neurol (Paris). 2016 Jan;172(1):59-68. doi: 10.1016/j.neurol.2015.07.013. Epub 2015 Dec 21.

    PMID: 26718592BACKGROUND

  • Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.

    PMID: 3804600BACKGROUND

  • Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284.

    PMID: 15714510BACKGROUND

  • Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14.

    PMID: 27079654BACKGROUND

  • Richardson D, Sheean G, Werring D, Desai M, Edwards S, Greenwood R, Thompson A. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry. 2000 Oct;69(4):499-506. doi: 10.1136/jnnp.69.4.499.

    PMID: 10990511BACKGROUND

  • Foley N, Pereira S, Salter K, Fernandez MM, Speechley M, Sequeira K, Miller T, Teasell R. Treatment with botulinum toxin improves upper-extremity function post stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2013 May;94(5):977-89. doi: 10.1016/j.apmr.2012.12.006. Epub 2012 Dec 19.

    PMID: 23262381BACKGROUND

  • Hesse S, Reiter F, Konrad M, Jahnke MT. Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial. Clin Rehabil. 1998 Oct;12(5):381-8. doi: 10.1191/026921598668275996.

    PMID: 9796928BACKGROUND

  • Hesse S, Jahnke MT, Luecke D, Mauritz KH. Short-term electrical stimulation enhances the effectiveness of Botulinum toxin in the treatment of lower limb spasticity in hemiparetic patients. Neurosci Lett. 1995 Dec 1;201(1):37-40. doi: 10.1016/0304-3940(94)12124-9.

    PMID: 8830307BACKGROUND

  • Picelli A, Smania N, Storti I, Munari D, Fontana C, Fiaschi A, Santilli V, Tamburin S. Immediate versus delayed electrical stimulation boosts botulinum toxin effect: A pilot study. Mov Disord. 2011 Aug 1;26(9):1784-5. doi: 10.1002/mds.23678. Epub 2011 Apr 29. No abstract available.

    PMID: 21538521BACKGROUND

  • Lee JM, Gracies JM, Park SB, Lee KH, Lee JY, Shin JH. Botulinum Toxin Injections and Electrical Stimulation for Spastic Paresis Improve Active Hand Function Following Stroke. Toxins (Basel). 2018 Oct 25;10(11):426. doi: 10.3390/toxins10110426.

    PMID: 30366407BACKGROUND

  • Sheean GL. Botulinum treatment of spasticity: why is it so difficult to show a functional benefit? Curr Opin Neurol. 2001 Dec;14(6):771-6. doi: 10.1097/00019052-200112000-00015.

    PMID: 11723387BACKGROUND

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine C Hay, PhD

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine C Hay, PhD

CONTACT

713-797-7675catherine.cooperhay@memorialhermann.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 3, 2020

Study Start

January 13, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

US(1)