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StrokeNCT04217187

Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

A study testing Neuromuscular Electrical Stimulation in people with Stroke, run by Texas Woman's University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Neuromuscular Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
13 Jan 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Catherine C Hay, PhD contact

713-797-7675

catherine.cooperhay@memorialhermann.org

United States1 site

  • TIRR Memorial Hermann

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: The Effect of Electrical Stimulation Post Botulinum Toxin Injections on Functional Use of the Hemiparetic Upper Extremity

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.

Read the detailed description

This is a pragmatic investigation that will utilize a two group comparison to compare electrical stimulation to a sham stimulation in individuals who are scheduled to receive botulinum toxin injections to their upper extremity for spasticity management. The electrical stimulation will be to the antagonist muscles of the injected muscles of the upper extremity and will be administered for 4 weeks post injections.

Conditions
Stroke
Being tested
Neuromuscular Electrical Stimulation, Sham Electrical Stimulation
Keywords
Botulinum Toxins, Spasticity, Upper Extremity, Electrical Stimulation
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical StimulationDevice

    Upper extremity neuromuscular electrical stimulation

  • Sham Electrical StimulationDevice

    Sensory only upper extremity electrical stimulation

Study groups in NCT04217187
Study groupRoleWhat they receive
Electrical Stimulation GroupExperimentalThis arm will receive neuromuscular electrical stimulation to the antagonist muscles of the upper extremity.
Receives: Device: Neuromuscular Electrical Stimulation
Sham Stimulation GroupSham comparatorThis arm will receive sensory stimulation without muscle contraction to the antagonist muscles of the upper extremity.
Receives: Device: Sham Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 1 month and 6 months after injections

Secondary outcomes (5)

  1. Action Research Arm Test

    Standardized measure of upper extremity function. The total score ranges from 0-57. A higher score indicates better arm function.

    Measured: Baseline, 1 month and 6 months

  2. Box and Block Test

    Standardized measure of upper extremity function. The score is the number of blocks transported within one minute. A higher score indicates better arm function.

    Measured: Baseline, 1 month and 6 months after injections

  3. Motor Activity Log

    Structured interview to measure perceived function of the upper extremity during daily tasks. There is a separate score for the amount of use and how well measures. Each scale ranges from 0-5 and a higher score indicates better arm function.

    Measured: Baseline, 1 month and 6 months after injections

  4. Modified Ashworth Scale for the Upper Extremity

    Measure of spasticity. Each muscle group (i.e. elbow flexors) is scored from 0-4 with a 0 indicating no increase in muscle tone and a 4 indicating the affected part is rigid. A decrease in score indicates a decrease in spasticity.

    Measured: Baseline, 1 month and 6 months

  5. Numeric Pain Rating Scale

    Self report of current, best and worst pain of upper extremity in the past 24 hours. Scale ranges from 0-10 with a 0 indicating no pain and a 10 indicating severe pain. A decrease in score indicates less pain.

    Measured: Baseline, 1 month and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2020
  2. Study start13 Jan 2020 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04217187
Sponsor's protocol ID
IRB-FY2020-43
Status last verified
Jan 2020
First submitted
2 Jan 2020
Last updated
7 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28122885

  • 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.

    PubMed 26718592

  • 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.

    PubMed 3804600

  • 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.

    PubMed 15714510

  • 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.

    PubMed 27079654

  • 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.

    PubMed 10990511

  • 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.

    PubMed 23262381

  • 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.

    PubMed 9796928

  • 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.

    PubMed 8830307

  • 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.

    PubMed 21538521

  • 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.

    PubMed 30366407

  • 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.

    PubMed 11723387

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation in people with Stroke, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Catherine C Hay, PhD (713-797-7675, catherine.cooperhay@memorialhermann.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage (time frame: Baseline, 1 month and 6 months after injections). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04217187, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020; AzTrials last refreshed its copy on 4 Nov 2026.

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