A Study on Safety of tDCS One-shot in UCP

IRCCS Fondazione Stella Maris

Status: Completed

Conditions: Hemiplegic Cerebral Palsy

Treatments: Device: real tDCS; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03137940

Safety_tDCS1.0

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 10 to 28 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic Unilateral Cerebral Palsy
• Informed consent

Exclusion criteria

• Any contraindication for tDCS

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

real tDCS

Experimental group

Description:

one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator. The anode electrode is placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode is placed in the supraorbital region (SO) of the contralateral hemisphere.

Treatment:

Device: real tDCS

Sham tDCS

Sham Comparator group

Description:

one-shot of sham tDCS session with BrainStim Stimulator (20 minutes). The montage of the electrodes will be placed as in the experimental session i.e.the anode electrode will be placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode in the supraorbital region (SO) of the contralateral hemisphere.

Treatment:

Device: sham tDCS