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

• ClinicalTrials.gov Identifier: NCT03425669
• Recruitment Status: Recruiting
• First Posted: February 7, 2018
• Last Update Posted: September 21, 2021
• Sponsor: Lund University
• Information provided by (Responsible Party): Lund University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
ADHD	Device: Stochastic Vestibular Stimulation; Device: Sham stimulation; Drug: Active medication	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

Intervention Model Description

Patients 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.

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 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.

• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Participants will be randomized to placebo or stimulant medication during assessments. Participants will be unaware if they will get sham stimulation or SVS (but not the test administrator).
• Primary Purpose: Treatment
• Official Title: Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children
• Actual Study Start Date: May 1, 2019
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2027

Arms and Interventions

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 Name: 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 Name: 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 Name: Auditory white noise stimulation

Outcome Measures

Primary Outcome Measures :

1. Spanboard task [ Time Frame: Ten weeks ]
   Test of visuo-spatial working memory
2. AVLT [ Time Frame: Ten weeks ]
   Auditory Verbal Learning Test
3. Go No- go test [ Time Frame: Ten weeks ]
   Test of impulse inhibition

Secondary Outcome Measures :

1. Soft- signs test [ Time Frame: Ten weeks ]
   Test of minor neurological deficits
2. Flower trail [ Time Frame: Ten weeks ]
   Test of perception, fine motor function and motor planning
3. Finger tapping task [ Time Frame: Ten weeks ]
   Test of timing

Eligibility Criteria

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

Criteria

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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Contacts and Locations

Contacts

Contact: Peik Gustafsson, MD, PhD; +46736250674; Peik.Gustafsson@med.lu.se

Locations

Sweden

Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University; Recruiting

Lund, Skane, Sweden, 221 85

Contact: Peik Gustafsson, MD, PhD +46736250674 Peik.Gustafsson@med.lu.se

Sponsors and Collaborators

Lund University

Investigators

• Principal Investigator: Peik Gustafsson, MD, PhD; Department of clinical sciences, Lund Uniersity

More Information

• Responsible Party: Lund University
• ClinicalTrials.gov Identifier: NCT03425669
• Other Study ID Numbers: Sponsor
• First Posted: February 7, 2018
• Last Update Posted: September 21, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:

Acoustic and vestibular noise stimulation

Additional relevant MeSH terms:

Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents