Measuring Fidelity of Constraint-Induced Movement Therapy Delivery with Combined Neuromodulation (Transauricular Vagal Nerve Stimulation)

Non-invasive brain stimulation (NIBS), including transauricular vagal nerve stimulation (taVNS), is combined with therapies (Dawson et al, 2021), such as constraint-induced movement therapy (CIMT) to boost treatment impact for infants with hemiplegia (McGloon et al, 2023). It is critical to assure fidelity to intervention protocols when combining NIBS with intensive therapy to support translation into clinical settings.

AIM: To determine if therapists can deliver high fidelity CIMT while using self-triggering taVNS.

METHOD: Prospective, open label, IRB-approved pilot trial for 3 infants, 6-18 months of age, with hemiparesis who received 40 hours of CIMT combined with taVNS (NCT05101707). Therapists provided signature CIMT approach during video-recorded sessions. Videos from weekly sessions were reviewed by 2 separate reviewers and scored using the Fidelity of Implementation Measure (FIRM); 4-point scale from does not meet fidelity (1) to meets high fidelity to CIMT protocols (4) (Ramey et al, 2019). Infant motor outcomes were collected at pre-, post-CIMT and 3-month follow-up using the QUEST, GMFM-88, and DAYC-2.

RESULTS: 24 videos of 3 infants reviewed resulted in an average FIRM score range of 3.54-3.73; indicating therapists adhered to intervention components with only minor exceptions that did not compromise CIMT protocol. Children tolerated the taVNS stimulation during CIMT and the handheld trigger was easy for therapist to use. All 3 infants showed significant gains in assessments relative to their baseline. Infant 1 had marked gains in arm/hand function (QUEST Δ=40.63). Infant 2 had gains in gross motor function for transitional movements (GMFM Pre: 32, Post: 55, Δ=23). Infant 3 showed gains on all assessments.

CONCLUSION: CIMT combined with non-invasive taVNS can be delivered with consistent fidelity to treatment protocols.

IMPACT: Incorporation of a fidelity measure assures effective treatment delivery when combining intensive therapy with NIBS.

References

Dawson, J., Liu, C. Y., Francisco, G. E., Cramer, S. C., Wolf, S. L., Dixit, A., Alexander, J., Ali, R., Brown, B. L., Feng, W., DeMark, L., Hochberg, L. R., Kautz, S. A., Majid, A., O’Dell, M. W., Pierce, D., Prudente, C. N., Redgrave, J., Turner, D. L., . . . Kimberley, T. J. (2021). Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): A randomised, blinded, pivotal, device trial. The Lancet (British Edition), 397(10284), 1545–155

McGloon, K., Coker-Bolt, P., Badran, B., Humanitzki, E., Schroeder, J., & Jenkins, D. (2023). Combining taVNS with early CIMT to improve health outcomes of infants: A case report. Brain Stimulation, 16(2), 7. https://doi.org/10.1016/j.brs.2023.03.031

Ramey, S. L., DeLuca, S., Stevenson, R. D., Case-Smith, J., Darragh, A., & Conaway, M. (2019). Children with hemiparesis arm and movement project (CHAMP): Protocol for a multisite comparative efficacy trial of paediatric constraint-induced movement therapy (CIMT) testing effects of dosage and type of constraint for children with hemiparetic cerebral palsy. BMJ Open, 9(1), e023285. https://doi.org/10.1136/bmjopen-2018-023285

Hand, B. N., Darragh, A. R., & Persch, A. C. (2018). Thoroughness and psychometrics of fidelity measures in occupational and physical therapy: A systematic review. The American Journal of Occupational Therapy, 72(5), 7205205050p1–7205205050p10. https://doi.org/10.5014/ajot.2018.025510