A Study on Safety of tDCS One-shot in UCP

NCT ID: NCT03137940

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2017-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

real tDCS

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.

Group Type: EXPERIMENTAL

real tDCS

Intervention Type: DEVICE

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

Sham tDCS

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.

Group Type: SHAM_COMPARATOR

sham tDCS

Intervention Type: DEVICE

one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.

Interventions

real tDCS

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

Intervention Type: DEVICE

sham tDCS

one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic Unilateral Cerebral Palsy
• Informed consent

Exclusion Criteria

• Any contraindication for tDCS

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Cioni, MD

Role: STUDY_DIRECTOR

IRCCS Fondazione Stella Maris, Università di Pisa

Locations

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy

Countries

Italy

References

Inguaggiato E, Bolognini N, Fiori S, Cioni G. Transcranial Direct Current Stimulation (tDCS) in Unilateral Cerebral Palsy: A Pilot Study of Motor Effect. Neural Plast. 2019 Jan 15;2019:2184398. doi: 10.1155/2019/2184398.

Reference Type: DERIVED

PMID: 30733800 (View on PubMed)

Other Identifiers

Safety_tDCS1.0

Identifier Type: -

Identifier Source: org_study_id