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Safety and Efficacy of tDCS in Pediatric DoC

NCT05929274 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

Summary

Background: Despite established evidence supporting the use of tDCS in the adult patient with disorders of consciousness, its use in paediatric patients with brain injury is still limited. Regarding the use of tDCS in paediatric patients with DoC, the scientific evidence still appears to be preliminary about the safety profile and requires further data before investigating efficacy on a broad scale. In fact, although the method has been shown to be safe in other clinical conditions, efficacy and tolerability in children with DoC may vary significantly depending on differences in activation threshold and the presence of underlying pathological electrical activity The implementation of clinical trials investigating the safety and tolerability of tDCS in paediatric patients with DoC now represents an essential first step for a future determination of the efficacy of this method in a population for which therapeutic options are currently extremely limited Objective: The study aim to verify the safety of tDCS treatment and to evaluate the effectiveness of stimulation of the left dorsolateral prefrontal cortex by tDCS in promoting improvement in the level of consciousness in paediatric patients with Disorders of Consciousness.

Method: in this mono-center, randomised, double blind cross-over controlled pilot study, real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of paediatric patients with disorders of consciousness for two weeks, followed by two weeks of washout, then real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex for other two weeks, followed by another two weeks of washout.

Conditions

  • Disorder of Consciousness

Interventions

DEVICE

tDCS

Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 milliampere (mA) from the onset of stimulation and applied for 20 minutes.

DEVICE

sham tDCS

For the sham condition (sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.

Sponsors & Collaborators

  • Giovanna Cristella

    lead OTHER

Principal Investigators

  • Giovanna Cristella, MD · IRCCS Fondazione Don Carlo Gnocchi ONLUS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929274 on ClinicalTrials.gov