Virtual Reality Therapy and Transcranial Direct Current Stimulation in Cerebral Palsy.
NCT04044677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-08-07
Summary
A double-blinded randomized controlled crossover trial will be conducted, and all participants will undertake non-immersive VR tasks and tDCS-active or tDCS-sham. Group 1 will start with ten sessions of tDSC-active combined to VR tasks. After one-month washout, this group will be reallocated to another 10 sessions with tDCS-sham combined to VR tasks. In contrast, Group 2 will do the opposite protocol (participants will start allocated to ten sessions of TDCS-sham and VR tasks, and after one-month washout period will be reallocated to ten sessions of tDCS-active and VR tasks). All protocol will have the assessment of Autonomic Nervous System, through Heart Rate Variability Analysis.
Conditions
- Cerebral Palsy
Interventions
- DEVICE
-
tDSC-active
10 sessions of active Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of sham Transcranial Direct Current Stimulation
- DEVICE
-
tDCS-sham
10 sessions of sham Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of active Transcranial Direct Current Stimulation
Sponsors & Collaborators
-
University of Sao Paulo
lead OTHER
Principal Investigators
-
Talita D Silva, PhD · University of Sao Paulo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 5 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-20
- Primary Completion
- 2019-07-20
- Completion
- 2019-08-01
Countries
- Brazil
Study Locations
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