Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Palsy
  • Hemiplegia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Children will be randomized to receive either real or sham tDCS plus robotic training. Children in the sham group will be given the opportunity to repeat the protocol and receive real stimulation after they complete the sham protocol.Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: tDCS will be blinded in that even children in the sham group will receive a low level of stimulation for a brief period.Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 17 years
Gender
Both males and females

Description

This sham-controlled, double-blind study will be completed at Blythedale Children's Hospital. Detailed procedures Robotic Device and Patient Position The investigators will use existing robots at Blythedale, which are FDA approved robotic devices that move the shoulder-and-elbow, or wrist-and-forear...

This sham-controlled, double-blind study will be completed at Blythedale Children's Hospital. Detailed procedures Robotic Device and Patient Position The investigators will use existing robots at Blythedale, which are FDA approved robotic devices that move the shoulder-and-elbow, or wrist-and-forearm, or the Typo Amadeo digit training robot. All robots: The subject will sit in a foam-padded chair facing the robot and a video screen. Planar (shoulder-elbow) and wrist robots: The arm will be abducted, forearm supported, and hand lightly grasping the robot handle, and velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's arm. Amadeo: The arm will be abducted, forearm supported, and digits attached to the robot with magnets. Velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's fingers. Robotic Training Participants will receive a total of 12 sessions comprising 1 hour of interactive robotic training. Participants will have two to four study visits per week. During one visit, the child will receive tDCS + 1 hr training on the shoulder-elbow MIT Manus robot, and on the second visit of the week, the child will receive tDCS + 1 hr training on the wrist MIT Manus robot. The interactive robot features involve visuomotor tasks, moving the robotic manipulandum according to targets on a computer screen mounted at eye level. A key feature of MIT robots is the low near isotropic inertia and reduced friction in the robot arm so that, when appropriate, it can "get out of the way." The force required to move the robotic arm is minimal, comparable to moving unrestricted, and if a patient cannot move the robot arm, it will guide the limb to provide an adaptive sensorimotor experience. Transcranial Direct Current Stimulation A current up to 1.5mA current will be delivered using surface rubber-carbon electrodes (35cm2) with surrounding saline soaked sponges (0.9% NaCl) by a battery driven, constant current stimulator (maximum output 2mA). Participants will receive stimulation for 20 minutes while seated (before robotic motor training), with the anode over the optimal site for first dorsal interosseous (FDI) as identified using TMS, and the cathode on the contralateral supraorbital area. Sham tDCS: comparable set-up to real tDCS, 30 sec real current ramping to current up to 1.5mA at commencement, then after 5 sec a slow decrease but to no current sustained for 20mins.

Tracking Information

NCT #
NCT03145532
Collaborators
Not Provided
Investigators
Not Provided