A Study on Safety of tDCS One-shot in UCP

NCT03137940 | Completed DMC

• 1 other identifier: Safety_tDCS1.0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Unilateral Cerebral Palsy; tDCS; Safety; Upper Limb functions

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]

  An adapted and child-friendly safety and tolerability questionnaire will be used for children and adolescent, while for young adults a questionnaire already used for this evaluation will be proposed. To explore the long-term safety the questionnaire is enriched with questions about quality of sleep, mood and activities to be answered after 24 hours of tDCS session

  The questionnaire will be filled in immediately after the tDCS session (T1), at 1 hour and half from T1 (T2) and, on call, at 24 hours from the tDCS session (T3)

Secondary Outcomes (4)

• Changes in heart rate [heartbeats per minute]

  At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2)

• Changes in blood pressure [mmHg]

  At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2)

• Changes in Box and Block Test (BBT)

  At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2)

• Changes in Hand Grip

  At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2)

Study Arms (2)

real tDCS

EXPERIMENTAL

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.

Device: real tDCS

Sham tDCS

SHAM COMPARATOR

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.

Device: sham tDCS

Interventions

real tDCS DEVICE

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

real tDCS

sham tDCS DEVICE

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

Sham tDCS

Eligibility Criteria

• Age: 10 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Symptomatic Unilateral Cerebral Palsy
• Informed consent

You may not qualify if:

• Any contraindication for tDCS

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy

Location

Related Publications (1)

• 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.

  PMID: 30733800 DERIVED

Study Officials

• Giovanni Cioni, MD

  IRCCS Fondazione Stella Maris, Università di Pisa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medical device randomly assigns, to each subject, the sequence of the type of sessions, so no one knows the kind of session performed.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 3, 2017
• Study Start: March 20, 2017
• Primary Completion: October 20, 2017
• Study Completion: December 30, 2017
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)