NCT03137940

A Study on Safety of tDCS One-shot in UCP

A Study on Safety and Feasibility of a Session of Transcranial Electrical Stimulation (tDCS "One-shot") in Children and Young Adults With Unilateral Cerebral Palsy (UCP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: IRCCS Fondazione Stella Maris · Academic / Other
• Sex: All
• Age: 10 Years – 28 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the safety and the feasibility of transcranial Direct Current Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short term, Upper Limb (UL) functions.

Detailed description

Unilateral Cerebral Palsy (UCP) represents the most frequent form of CP; the upper limb (UL) is generally more affected than the lower limb with an impact in "activity" and "participation" areas. The non-invasive brain stimulation techniques (NIBS), such as transcranial Direct Current Stimulation (tDCS), appear able to modulate neuronal plasticity processes even more late in age attracting great interest for their potential fallout in the field of rehabilitation. The effects of tDCS in recovery of motor function has more investigated in adults, while in the pediatric population studies on safety and efficacy are still few and not conclusive. This study aims to evaluate the safety and the feasibility of tDCS session in children and young adults with UCP both in short term and in follow up (up to 24 hrs after the tDCS session). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in short term, UL functions. For the study 6 children (aged 10-17 years) and 6 young adults (aged 18-28 years) with UCP will be recruited. Each subject receives, randomly, a real session and a sham session of tDCS with BrainStim Stimulator. Before (T0), immediately after (T1) and after 1 hour and half (T2) to each tDCS session (real or sham) heart rate, blood pressure and UL functions will be measured. Moreover the subject fills in an ad hoc questionnaire on safety at T1 and T2 and, on call, at 24 hours after the sessions (T3).

Conditions

• Hemiplegic Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	real tDCS	one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.
DEVICE	sham tDCS	one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-10-20
• Completion: 2017-12-30
• First posted: 2017-05-03
• Last updated: 2019-08-08

Locations

1 site across 1 country: Italy