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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Device: Sham stimulation; Drug: Active medication; Device: Stochastic Vestibular Stimulation

Detailed Description

Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5-7% (e.g. Ullebo et al., 2012). Today the most common treatment approach is stimulant medication, e.g. methylphenidate (Greenhill et al., 2002; Wigal et al., 2011). However there are many concerns about medication: i) best dose for cognitive functioning and adapted school behavior differs (Hale et al., 2011), ii) it is not even evident that medication improves learning processes (Molina et al., 2009), iii) concerns regarding potential for drug abuse (Gordon et al., 2004); and iv) uncertainties regarding long term effects of drug use on the developing brain (Andersen, 2005).

In both national and international guidelines of ADHD care multimodal treatment is recommended (Young & Amarasinghe, 2010), but most patients only receive pharmacological treatment, sometimes in combination with parent training. If auditory or vestibular noise, as the present project suggests, could be a complement or an alternative to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.

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). Inattentive and low achieving school children have been shown to improve their memory recall when exposed to noise, whereas attentive and high achieving children perform worse during noise exposure (Helps et al., 2014; Söderlund & Sikström, 2008, 2012; Söderlund et al., 2010).

Vestibular noise benefit: Vestibular stimulation has since long been demonstrated to increase hippocampal activity and hippocampus is well demonstrated to be of crucial importance in detecting and holding on to spatial targets showing that hippocampus is of fundamental for both spatial orientation and learning in general (Moser et al., 2015). Therefore it is not surprising that external stochastic vestibular stimulation (SVS) exerts beneficial effects in different domains, e.g. balance in healthy astronauts (Mulavara et al., 2011), in Parkinson patients (Pal et al., 2009; Samoudi et al., 2014) and response times in continuous performance task (Yamamoto et al., 2005). The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). 1. The first objective is to systematically evaluate the effects of stochastic vestibular noise on cognitive task performance and to compare these results with the ones of stimulant medication using a double blind RCT (Random Control Trial) design.

The second objective is to implement a practical application, to evaluate if auditory noise can be beneficial in an every day school setting by the use of an iPhone application (see: www.smartnoise.se).

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peik Gustafsson, MD, PhD; Phone Number: +46736250674; Email: Peik.Gustafsson@med.lu.se

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 221 85
      • Recruiting
      • Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University
      • Contact: Peik Gustafsson, MD, PhD; Phone Number: +46736250674; Email: Peik.Gustafsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Children and adolescents with a diagnosis of ADHD and control children without at diagnosis.

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Exclusion Criteria: Intellectual disability, psychosis, severe depression or anxiety

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo medication and sham stimulation; Patients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.	Device: Sham stimulation; Patients will receive sham stimulation in place of active vestibular stimulation.
Active Comparator: Active medication; Patients are randomly chosen to the group who will get active medication without stimulation.	Drug: Active medication; Patients will be examined with and without medication.; Other Names: Concerta, Ritalin, Methylphenidate, Equasym or Medikinet
Sham Comparator: Active stimulation; Patients are randomly chosen to the group who will get acitive stimulation without taking medicine.	Device: Stochastic Vestibular Stimulation; 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.; Other Names: Auditory white noise stimulation
Active Comparator: Controls with sham stimulation; Controls without ADHD are randomly chosen to the group who will get sham stimulation.	Device: Sham stimulation; Patients will receive sham stimulation in place of active vestibular stimulation.
Sham Comparator: Controls with active stimulation; Controls without ADHD are randomly chosen to the group who will get active stimulation.	Device: Stochastic Vestibular Stimulation; 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.; Other Names: Auditory white noise stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spanboard task	Test of visuo-spatial working memory	Ten weeks
AVLT	Auditory Verbal Learning Test	Ten weeks
Go No- go test	Test of impulse inhibition	Ten weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft- signs test	Test of minor neurological deficits	Ten weeks
Flower trail	Test of perception, fine motor function and motor planning	Ten weeks
Finger tapping task	Test of timing	Ten weeks

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Peik Gustafsson, MD, PhD, Department of clinical sciences, Lund Uniersity

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Acoustic and vestibular noise stimulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: SPONSoR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No