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Clinical Trial Summary

Current exploratory single site open label unblinded trial, will assess the feasibility of active tDCS in the home setting under caregiver and remote investigator supervision and direction. The study population will consist of 10 children between ages 8 - 17 years and 365 days with a history of a brain bleed or stroke. An estimated 3.6 per 1,000 births in the United States are affected by stroke or brain bleeds which can lead to Cerebral Palsy (CP), a developmental disorder associated with motor impairment. While, the majority of rehabilitation approaches focus on behavioral repetition to improve gait and upper extremity function, these therapies can require extensive practice times and extent of recovery is variable. Non-invasive brain stimulation (NIBS), specifically transcranial direct current stimulation (tDCS), provides an approach for modulation of neuroplasticity that is safe, inexpensive, and portable. Furthermore, rehabilitation approaches combined with tDCS have shown promise to improve motor function recovery and quality of life after stroke in adults. Integrating the application of NIBS may allow for enhanced rehabilitation during the enhanced neuroplastic period of childhood and NIBS has demonstrated promising outcomes in increasing the rate and extent of recovery. The Gillick laboratory has shown that in children with CP the use of tDCS is safe, feasible, and successful at modifying motor performance when in combination with other physical therapy interventions. tDCS is not currently available to subjects without taking part in the study. In this study, investigators plan to administer tDCS in the remote setting during a synchronous zoom call with trained laboratory members. To ensure the device's is safely used in the home setting only during designated times, a pre-set code will be required to administer stimulation via the device. This intervention has the potential to improve motor rehabilitation outcomes and can offer telehealth access, which may reduce treatment cost and improve access to limited access to clinic or hospital facilities. Ultimately, this will contribute to a wider reach in improving quality of life across the lifespan in children with CP.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05071586
Study type Interventional
Source University of Wisconsin, Madison
Contact Catarina Saiote Ferreira Leite
Phone 608-262-3079
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 2021
Completion date October 2022

See also
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Completed NCT04509544 - Satisfaction and Preferences About Motor Rehabilitation in People With Cerebral Palsy: ESPaCe, a French Survey
Completed NCT01491152 - Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age N/A
Completed NCT01468350 - Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy Phase 1
Completed NCT03756571 - Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations N/A
Completed NCT02003755 - The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy N/A