Altering brainwaves to help symptoms of mild cognitive impairment
| ISRCTN | ISRCTN53100329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53100329 |
| IRAS number | 320617 |
| Secondary identifying numbers | IRAS 320617 |
- Submission date
- 25/04/2024
- Registration date
- 28/05/2024
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Research has demonstrated that certain brain waves are distorted as you age. This may be related to cognitive decline, specifically conditions such as Mild Cognitive Impairment (MCI) or dementia. Previous studies show that specific sound stimulations can manipulate these brain waves to attenuate symptoms of these conditions. Researchers are investigating a non-invasive method called Continuous Amplitude Modulated Sound Stimulation (CAMSS) that aims to modulate brainwaves in specific frequencies using sound. Unlike conventional methods that use artificial sounds, CAMSS seamlessly embeds these frequencies into familiar environmental sounds, making the experience natural and unobtrusive for individuals with MCI. This research holds immense potential for individuals dealing with dementia-related conditions. By introducing a simple method - listening to modified sounds - the aim is to offer a new accessible way to alleviate dementia symptoms, potentially enhancing the quality of life for those affected.
Who can participate?
Adults aged 55 – 75 years with a diagnosis of Mild Cognitive Impairment
What does the study involve?
Participants will engage in a single session lasting 2 to 2.5 hours at King’s College London. During this time, they will undergo brain imaging, specifically, electroencephalogram (EEG) monitoring, while listening to different types of sounds. Additionally, they will perform cognitive tasks designed to assess attention, memory, and cognitive control.
What are the possible benefits and risks of participating?
There are no current direct benefits to participants individually, but the research may benefit people with mild cognitive impairment and Alzheimer's disease in the future if the research successfully develops CAMSS into a therapeutic method for attenuating the pathology of the conditions. Moreover, participants will have the opportunity to learn more about research using EEG methods.
If all standard procedures are followed there are no known risks of using electroencephalogram (EEG). Participants may feel the gel is cold or they may feel the blunt needle during the EEG preparation, but this will not be painful. All details of the EEG procedure will be outlined in the information sheet before their visit. The researchers will constantly monitor the participants to ensure they are comfortable.
Where is the study run from?
King’s College London (UK)
When is the study starting and how long is it expected to run for?
February 2024 to December 2024
Who is funding the study?
Tianqiao and Chrissy Chen Institute (USA)
Who is the main contact?
Dr Gráinne McLoughlin, grainne.mcloughlin@kcl.ac.uk
Contact information
Public, Scientific, Principal Investigator
Memory Lane
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0001-5785-9527 |
|---|---|
| Phone | +44 (0)20 7836 5454 |
| grainne.mcloughlin@kcl.ac.uk |
Study information
| Study design | Single-centre observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Laboratory |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | SoundMind-MCI: sound entrainment of brain oscillations in mild cognitive impairment |
| Study acronym | SM-MCI |
| Study objectives | To conduct a comparison study of electroencephalogram spectral changes between Continuous Amplitude Modulated Sound Stimulation and classic sound stimulation in a clinical sample of participants with Mild Cognitive Impairment. |
| Ethics approval(s) |
Approved 26/03/2024, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8229; brent.rec@hra.nhs.uk), ref: 24/PR/0231 |
| Health condition(s) or problem(s) studied | Mild cognitive impairment |
| Intervention | The primary aim is to conduct a comparison study of electroencephalogram (EEG) spectral changes between Continuous Amplitude Modulated Sound Stimulation (CAMSS) and classic sound stimulation in a clinical sample of age-matched (to Sample A of healthy older participants aged 55-75 years old, Ethical Clearance Reference Number: LRS/DP-22/23-33852) participants with Mild Cognitive Impairment (MCI). To do so, the researchers will measure EEG spectral changes while MCI participants listen to (1) CAMSS, (2) identical unmodulated sounds and (3) click trains. As a secondary, exploratory objective the researchers will also measure the cognitive effects of modified spectral states induced by CAMSS. Specifically, they aim to (1) examine reaction time and errors during the arrow flanker task, (2) examine event-related indices of cognitive control during the arrow flanker task, including the N2 and theta power, (3) examine reaction time and errors during a semantic and source memory task, and (4) examine event-related potential indices during the semantic and source memory task, including theta power and the N2. To do so, the researchers will repeat the same three sound conditions while the MCI participants complete the arrow flanker task and the semantic and source memory tasks. All participants will complete every stage of the study. |
| Intervention type | Other |
| Primary outcome measure | 1. The entrainment of gamma oscillations measured by electroencephalogram (EEG) during testing (only one timepoint) |
| Secondary outcome measures | 1. Cognitive function measured by EEG, specifically the N2 and theta power during the cognitive task during testing (only one timepoint) 2. Cognitive function measured by reaction time during the cognitive task during testing (only one timepoint) |
| Overall study start date | 01/02/2024 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 55 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged between 55 and 75 years old 2. Has a diagnosis of MCI recognised by the South London and Maudsley Hospital |
| Key exclusion criteria | 1. Hearing levels not within sufficient range (normal and mild hearing loss [presbycusis] is accepted) as determined by the hearing test 2. Any psychiatric or neurological disorder indicated by the participant other than MCI 3. Cardiac disease 4. Uncorrected visual problems 5. Unable to follow the protocol e.g. due to language barriers meaning questionnaires/interviews cannot be conducted 6. Currently taking part in interventional studies 7. Participants who have allergies or sensitivity to gel |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 31/07/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE5 8AF
United Kingdom
Sponsor information
University/education
Memory Lane
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| slam-ioppn.research@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to IP restrictions. |
Editorial Notes
04/06/2024: The ethics approval was added.
25/04/2024: Study's existence confirmed by the London - Brent Research Ethics Committee.
