Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2024-09-30

Brief Summary

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This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin

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Detailed Description

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Background: Children with neurodevelopmental disorder such as cerebral palsy (CP) and autistic spectrum disorder have poor sleep. Poor sleep in these children may lead to worsening spasticity, increased caregiver burden and poorer quality of life. Use of Melatonin is a common treatment for sleep but it is not helpful in sleep maintenance. More sedating pharmacological options have side-effects if given long-term. A safe and non-invasive intervention that can improve sleep in children with neurodevelopmental disorder is needed. In recent years, non-invasive brain stimulation such as transcranial electrical stimulation (TES) has emerged as a potential treatment to improve sleep in adult patients with major depressive disorders, bipolar disorders, migraine and Parkinson's disease. Transcranial pulsed current stimulation (tPCS) is a form of TES that has increasingly gained attention as a novel safe and cost-effective treatment modality for spasticity in children with CP and for improvement of gait in adults with Parkinson's Disease.

Hypothesis: tPCS is effective in improving total sleep time (TST) in children with neurodevelopmental disorder.

Aim: We aim to objectively evaluate whether tPCS can increase TST in children with neurodevelopmental disorder, compared to Melatonin.

Methodology and Analytical approach: Based on 80%power, alpha 0.05 and 20%drop-out rate, this is a single centre randomized control, crossover trial using Balaam's design that enrols 40 children with neurodevelopmental disorder: Patients will be treated with home-based tPCSor Melatonin over 8 weeks. All patients will do sleep actigraphy and sleep questionnaire using the Sleep Disturbance Scale for Children at baseline and at the end of trial.

Clinical Significance: tPCS could serve as a potential alternative for pharmacotherapy in treatment of insomnia in children with neurodevelopmental disorders. This could change clinical practice and improve quality of care for these children.

Conditions

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Insomnia Neurodevelopmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover trial using Balaam's design

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor assessing sleep data will be blinded

Study Groups

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Intervention

Intervention group is transcranial pulse electrical stimulation

Group Type EXPERIMENTAL

transcranial pulsed current stimulation

Intervention Type DEVICE

A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.

Comparator

comparator is Melatonin

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

Melatonin

Interventions

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transcranial pulsed current stimulation

A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.

Intervention Type DEVICE

Melatonin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 4-16
* Neurodevelopmental disorder including cerebral palsy, autistic spectrum disorder, neurogenetic syndrome.
* Patients whose pre-intervention sleep questionnaire total score more than 46 and/or pre-intervention sleep questionnaire T-score more than 70 in any sleep domain
* Children agree to tPCS as per procedure and consent to the study, including need to shave hair at the site of stimulation at the occiput
* Parents/carers agree to tPCS as per visit schedule and procedure
* Medical practitioner's approval

Exclusion Criteria

* History of uncontrolled epileptic disorders and seizures, brain tumours or trauma and mental diseases, substance abuse or dependence, use of benzodiazepines, neuroleptic, serotonin or dopaminergic drugs, presence of metal/ electronic implant in brain/ body eg. shunt, cochlear implant, pacemaker or defibrillator, untreated known obstructive sleep apnoea or another previously diagnosed sleep disorder, and current involvement in other tDCS or rTMS trials. Patients with history of drug allergy to Melatonin will also be excluded.

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No