Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001331628
Ethics application status
Not yet submitted
Date submitted
26/11/2014
Date registered
18/12/2014
Date last updated
18/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of mild brain stimulation in children with attention deficit hyperactivity disorder (ADHD)
Scientific title
The effect of transcranial direct current stimulation in combination with occupational therapy on attention span, impulsivity and symptom severity in children with attention deficit hyperactivity disorder
Secondary ID [1] 285748 0
None
Universal Trial Number (UTN)
U1111-1164-5341
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 293635 0
Condition category
Condition code
Mental Health 293930 293930 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 293965 293965 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will investigate the effect of 20 min of 2mA anodal transcranial direct current stimulation (tDCS) in combination with 45 min of standard occupational therapy in 20 children diagnosed with mild to moderate attention deficit hyperactivity disorder. Children will undergo 10 weekly consecutive sessions of their standard occupational therapy of which 5 consecutive sessions of active and 5 consecutive sessions of sham tDCS will be randomly assigned by employing a double-blind cross-over design. The standard occupational therapy will be administered by an occupation therapist while the tDCS will be performed by qualified research staff.
Intervention code [1] 290705 0
Treatment: Devices
Comparator / control treatment
Randomised trial of sham versus active stimulation in a double-blind cross-over procedure. The current on- and offset of tDCS usually creates a tingling sensation over 30 seconds at the beginning of the stimulation. Only receiving the stimulation for 30 seconds will create the same sensation and will be used for 5 consecutive sessions as sham stimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 293700 0
Change in attention performance assessed by the results of a stop-signal task and will be compared between active versus sham stimulation
Timepoint [1] 293700 0
At baseline, after 5 sessions of active versus 5 sessions of sham stimulation
Primary outcome [2] 293795 0
Changes of impulsivity will be assessed by the results of a stop-signal task and compared between active versus sham stimulation
Timepoint [2] 293795 0
At baseline, after 5 sessions of active versus 5 sessions of sham stimulation
Secondary outcome [1] 311623 0
Symptom ratings of attention deficit hyperactivity symptoms, assessed by clinician using the "DSM-V: ADHD Symptom Checklist—Child and Adolescent Version"
Timepoint [1] 311623 0
At baseline, after 5 sessions of active versus 5 sessions of sham stimulation

Eligibility
Key inclusion criteria
First contact patients meeting the DSM-V criteria for mild to moderate Attention Deficit Hyperactivity Disorder
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking psychotropic medication, history of seizures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290316 0
Charities/Societies/Foundations
Name [1] 290316 0
Hunter Medical Research Institute
Country [1] 290316 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 289032 0
Other Collaborative groups
Name [1] 289032 0
Educare
(private children mental health care provider)
Address [1] 289032 0
Sky Central
Level 3, 28-38 Smart Street
Charlestown NSW 2290
Country [1] 289032 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292024 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292024 0
University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 292024 0
Australia
Date submitted for ethics approval [1] 292024 0
28/11/2014
Approval date [1] 292024 0
Ethics approval number [1] 292024 0

Summary
Brief summary
Applying a mild electrical current to the head is known to improve brain functions related to attention and learning without causing significant adverse side effects other than a mild local skin irritation at the stimulation site. The current study investigates stimulation effects whilst children - diagnosed with mild to moderate attention deficit hyperactivity disorder - undergo their regular occupational therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53102 0
Prof Ulrich Schall
Address 53102 0
PRC Translational Neuroscience & Mental Health Research
McAuley Centre - Mater Hospital
Edith Street
Waratah NSW 2298
Country 53102 0
Australia
Phone 53102 0
+61410492950
Fax 53102 0
Email 53102 0
[email protected]
Contact person for public queries
Name 53103 0
Prof Ulrich Schall
Address 53103 0
PRC Translational Neuroscience & Mental Health Research
McAuley Centre – Mater Hospital
Edith Street
Waratah NSW 2298
Country 53103 0
Australia
Phone 53103 0
+61410492950
Fax 53103 0
Email 53103 0
[email protected]
Contact person for scientific queries
Name 53104 0
Prof Ulrich Schall
Address 53104 0
PRC Translational Neuroscience & Mental Health Research
McAuley Centre – Mater Hospital
Edith Street
Waratah NSW 2298
Country 53104 0
Australia
Phone 53104 0
+61410492950
Fax 53104 0
Email 53104 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.