Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children

ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-18
SponsorLund University

About this trial

Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund \& Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016).

Participants and recruitment: Participants with an ADHD diagnosis using medication will be recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing children (TDC) and inattentive children without diagnosis will be recruited from schools in collaboration with the municipality.

Experimental design: All participants will perform a double-blind placebo cross over control study. ADHD participants will perform the entire test battery at three occasions with 2-3 weeks intermission in between tests. One occasion with placebo medication and sham SVS stimulation; one occasion with active SVS stimulation; and one occasion with active medication. TD children will only be tested twice while they will not be given any medication or placebo and just perform under SVS vs. sham conditions.

Test battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT) (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school setting. Our research group has developed an iPhone application (www.smartnoise.se) that is available at App-store right now. The study will last for about 5 months and participants will be 50 voluntary secondary school pupils that have documented attention difficulties as judged by their teachers. The application will be evaluated both by pupils, teachers and parents.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Stochastic Vestibular Stimulation

    Device

    Stochastic vestibular stimulation will be given by electric stimulation through electrodes place over the mastoid processes behind each ear. Auditory stimulation with stochastic white noise will be administrated through ear phones.

  • Sham stimulation

    Device

    Patients will receive sham stimulation in place of active vestibular stimulation.

  • Active medication

    Drug

    Patients will be examined with and without medication.

Treatment groups

70 Participants
are divided into 5 treatment groups
Group A: Placebo medication and sham stimulationActive comparator 1 intervention
Group B: Active medicationActive comparator 1 intervention
Group C: Active stimulationSham comparator 1 intervention
Group D: Controls with sham stimulationActive comparator 1 intervention
Group E: Controls with active stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Spanboard task

Test of visuo-spatial working memory

Time frame
Ten weeks
2

AVLT

Auditory Verbal Learning Test

Time frame
Ten weeks
3

Go No- go test

Test of impulse inhibition

Time frame
Ten weeks

Secondary outcomes

1

Soft- signs test

Test of minor neurological deficits

Time frame
Ten weeks
2

Flower trail

Test of perception, fine motor function and motor planning

Time frame
Ten weeks
3

Finger tapping task

Test of timing

Time frame
Ten weeks

Other outcomes

Sponsors and contacts

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