Sensory Modulation DisorderNCT03837795
Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity
A study testing Neurofeedback treatment in people with Sensory Modulation Disorder and Sensory Over-Responsivity, run by Tel Aviv University at 1 site in Israel.
Trial summary
Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Modulation Disorder, Sensory Over-Responsivity
- What is being tested?
- Neurofeedback treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale.
- free of analgesic medicines for no less than 24 hours before the sessions.
- independent functioning in the community.
- fluency in understanding and reading Hebrew
Who cannot join
- metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis
- acute or chronic pain.
- regular intake of neurological, psychiatric and analgesic medicines.
- participating in other therapies (i.e., cognitive therapies) at present.
- substance abuse.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency of Neurofeedback Therapy for Enhancing Participation in Occupations, Decreasing Pain Sensitivity, Improving Life Satisfaction and Brain Neural Activity in Adults With Sensory Over Responsivity - a Pilot Study
Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Altered neurophysiological processes in SOR are documented, revealing reduced electroencephalogram at rest and P300 amplitudes, the latter tested through event-related potentials (ERP). Both may explain the failure to regulate incoming sensory stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.
Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction and Goal Attainment Scaling (GAS) scores in adults with SOR.
Read the detailed description
In this serial experimental research design, 10 individuals with SOR aged 21-45 years will participate. A medical and demographic questionnaire and the Sensory Responsiveness Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks pre-treatment; 2. before the first treatment session; 3. after the last treatment session; and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300 component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power using electroencephalogram resting state, and electronic versions of the Satisfaction with Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a week, will be held at the same time of day.
Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent variables measures change over time.
- Being tested
- Neurofeedback treatment
- Keywords
- Neurofeedback, Sensory Modulation Disorder, Sensory Over-Responsivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback treatmentDevice
A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback therapy group | Experimental | Not described Receives: Device: Neurofeedback treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Satisfaction with Life Scale (SWLS)
assesses global life satisfaction
Measured: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
Goal Attainment Scaling (GAS)
a standardized therapeutic method used to evaluate the participants' progress toward their functional goals
Measured: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
To evaluate participants' participation level in the last month
Measured: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
Secondary outcomes (2)
Pain Sensitivity Questionnaire (PSQ)
a standardized self-report questionnaire assessing daily pain sensitivity
Measured: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Electroencephalogram (EEG) Resting State
To measure alpha band (8-12Hz) power
Measured: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 May 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Modulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837795
- Sponsor's protocol ID
- 1710.18
- Status last verified
- Apr 2021
- First submitted
- 8 Jan 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Neurofeedback Therapy for Enhancing Participation in Occupations, Decreasing Pain Sensitivity, Improving Life Satisfaction and Brain Neural Activity in Adults With Sensory Over Responsivity - a Pilot Study
- ClinicalTrials.gov ID
- NCT03837795
- Acronym / sponsor ID
- 1710.18
- Keywords
- Neurofeedback, Sensory Modulation Disorder, Sensory Over-Responsivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Altered neurophysiological processes in SOR are documented, revealing reduced electroencephalogram at rest and P300 amplitudes, the latter tested through event-related potentials (ERP). Both may explain the failure to regulate incoming sensory stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.
Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction and Goal Attainment Scaling (GAS) scores in adults with SOR.
Detailed description
In this serial experimental research design, 10 individuals with SOR aged 21-45 years will participate. A medical and demographic questionnaire and the Sensory Responsiveness Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks pre-treatment; 2. before the first treatment session; 3. after the last treatment session; and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300 component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power using electroencephalogram resting state, and electronic versions of the Satisfaction with Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a week, will be held at the same time of day.
Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent variables measures change over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback therapy group | Experimental | Device: Neurofeedback treatment |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale.
- free of analgesic medicines for no less than 24 hours before the sessions.
- independent functioning in the community.
- fluency in understanding and reading Hebrew
Key exclusion criteria (6 listed)
- metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis
- acute or chronic pain.
- regular intake of neurological, psychiatric and analgesic medicines.
- participating in other therapies (i.e., cognitive therapies) at present.
- substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback treatmentA treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude). | Device | Neurofeedback therapy group |
Primary outcome
The Satisfaction with Life Scale (SWLS)
Time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
assesses global life satisfaction
Goal Attainment Scaling (GAS)
Time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
a standardized therapeutic method used to evaluate the participants' progress toward their functional goals
The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
Time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
To evaluate participants' participation level in the last month
2 secondary outcomes
Pain Sensitivity Questionnaire (PSQ)
Time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Electroencephalogram (EEG) Resting State
Time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback treatment in people with Sensory Modulation Disorder and Sensory Over-Responsivity, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Satisfaction with Life Scale (SWLS) (time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.