AzTrials
AzTrials

Healthy ParticipantsMindStimNCT05999916

Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants

A study testing Personalized Miamind Neurostimulator in people with Healthy Participants and Healthy Population, run by Bottneuro AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The present study aims to assess the safety and feasibility of repeated transcranial alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy participants. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Participants, Healthy Population
What is being tested?
Personalized Miamind Neurostimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSwitzerland
Study dates
27 Dec 2023to 22 Mar 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
  • Able and willing to provide voluntary written Informed Consent and sign the ICF to participate in the study prior to any study-related procedure.
  • Must have the ability to comply with protocol-related tests, appointments, and procedures.
  • Age over 18 years old.
  • Knowledge of the German language (B1 or higher).
  • No history of intellectual or learning disability; at least 8 grades of school.
  • Non-disturbing hairstyle or headdress that enables electrode contact with the scalp judged by the investigator.

Who cannot join

  • Any acute or chronic disease/disorder (e.g., cerebral, psychiatric, cardiovascular, pulmonary, metabolic, skin etc.)
  • History of traumatic brain injury or other diseases of the central nervous system.
  • History of seizures, diagnosis of epilepsy, or abnormal (epileptiform) EEG, or immediate (1st-degree relative) family history of epilepsy.
  • Diagnosis of substance abuse.
  • Participant is under the influence of alcohol, and consumption of narcotics or benzodiazepines, or other sleeping medications prior to the procedure.
  • All female participants that are not post-menopausal (defined as at least 12 months of spontaneous amenorrhea in women over 45 years old) or surgically sterile (e.g. bilateral tubal ligation, hysterectomy, bilateral oophorectomy) will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study.
Show all 11Show fewer
  • Metal implants (excluding dental fillings) or devices such as a pacemaker, cardioverter defibrillator, medication pump, nerve stimulator, Transcutaneous Electrical Nerve Stimulator (TENS) unit, ventriculoperitoneal shunt, and cochlear implant, unless cleared by the study MD.
  • Contraindications for undergoing MRI.
  • Ongoing participation in any other interventional clinical study with an investigational drug or another MD within the 30 days preceding and during the present investigation.
  • Participants not suitable for the study based on a holistic consideration of the participant's history and the PI's medical expertise.
  • No vulnerable subject is enrolled on this study

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

Official title: A Prospective, Single-Arm, Monocentric Pilot Study to Evaluate the Safety and Feasibility of Transcranial Alternate Current Stimulation With the Miamind Neurostimulator in Healthy Participants

The present study aims to assess the safety and feasibility of repeated transcranial alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy participants. Based on the findings of this investigation, subsequent clinical trials assessing the efficiency of tACS by the Miamind Neurostimulator for treatment of Alzheimer's Disease will be conducted.

Read the detailed description

The pathological hallmarks of Alzheimer's Disease (AD) are extracellular amyloid-β (Aβ) plaques and intracellular neurofibrillary tangles of hyperphosphorylated tau deposition in the brain together with neuroinflammation and microglial activation. These alterations lead to synaptic dysfunction, neuronal loss, and subsequently to brain circuit and brain oscillation disruption, resulting in cognitive decline. Recent studies have shown a positive effect of neural entrainment at gamma frequency (30-80 Hz). Transcranial alternating current stimulation (tACS) utilizes low amplitude alternating currents, allowing for frequency and region-specific brain oscillation entrainment showing positive results regarding improvement of cognitive functions in healthy participants and Alzheimer's Disease patients. Miamind Neurostimulator is a patient specific MRI-based 3D printed medical device that permits electrical stimulation and recording on up to 32 electrode channels and thus allows for simultaneous, multifocal, and targeted brain stimulation. tACS is non- invasive, well tolerated by users and considered safe with no persistent adverse events reported.

Being tested
Personalized Miamind Neurostimulator
Keywords
Alzheimer Disease, tACS, Memory Problems, Cognitive Impairment, Cognitive Performance, Safety and Tolerability, Feasibility
Medical subject headings
Alzheimer Disease, Memory Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Miamind NeurostimulatorDevice

    60 min. 40 Hz max. 1mA / electrode \& total of max. 2 mA across all electrodes. 30- s ramp-up personalised intervention based on individual modelling of electric field distribution to maximise therapeutic effect in the target region. Three target regions, consecutively stimulated (20min each).

Study groups in NCT05999916
Study groupRoleWhat they receive
60 min session of 40Hz tACS by Miamind NeurostimulatorExperimentalThe clinical study will enroll eight (8) participants who will undergo four (4) tACS sessions (one per day) within 4 consecutive days. The tACS intervention will last 60 min in total. The stimulation frequency will be 40 Hz with max 1 mA/electrode and total of max 2 mA across all active electrodes (peak-to-baseline).
Receives: Device: Personalized Miamind Neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Incidence of Treatment-Emergent Adverse Events

    Safety of the Treatment defined as the proportion of study participants free of serious adverse device effects and unanticipated serious adverse device effects (SADE and USADE) assessed via a safety questionnaire and medical evaluation.

    Measured: up to 2 weeks

Secondary outcomes (5)

  1. Safety and comfort: questionnaire

    Adverse Events and comfort of tACS and the medical device are reported by questionnaires following stimulation of each target region at visit °3 \& °4 and following sequential stimulation of multiple target regions at visit °5 \& °6.

    Measured: up to 2 weeks

  2. Evaluation of functional impact of tACS on Attention and Concentration: d2-R attention test

    Changes in d2-R attention test are reported to document the functional impact of tACS on concentration and attention before and after stimulation of each target region at visit °3 \& °4 and before and after sequential stimulation of multiple target regions at visit °5 \& °6.

    The d2-R attention test measures processing speed, rule compliance, and quality of performance as estimation of attention and concentration and scores them as the following separate items: speed, concentration, carefulness. Each item is scored from 20-80. A higher score indicates better performance.

    Measured: up to 2 weeks

  3. Evaluation of functional impact of tACS on oscillatory activity: Electroencephalography (EEG)

    Quantification of EEG measurements to document the functional impact of tACS on oscillatory activity in individual frequency bands (delta, theta, alpha, beta, gamma) and EEG-biomarkers (alpha peak frequency, Vigilance) before and after stimulation of each target region at visit °3 \& °4 \& °5 \& °6.

    Measured: up to 2 weeks

  4. Cognitive Evaluation: Montreal Cognitive Assessment (MoCA)

    MoCA scores are documented before and after visit °3 and after visit °6 to evaluate the impact of repeated tACS on cognitive performance.

    The MoCA has a total scoring range of 0-30, with the score based on the number of correct answers made in each of the 7 following items: Visuospatial/Executive, Naming, Memory/delayed recall, Attention, Language, Abstraction, Orientation. Sub-scores and total score are reported.

    A lower total score indicate greater cognitive impairment.

    Measured: up to 2 weeks

  5. Participant coherence and satisfaction questionnaire

    The subjective impression and satisfaction of the participant regarding the device and the intervention is documented using a one-time questionnaire at the end of the study.

    Measured: up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start27 Dec 2023
  3. Primary completion22 Mar 2024
  4. Study completion22 Mar 2024

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
The present study aims to assess the safety and feasibility of employing repeated (4 sessions at 4 days) transcranial alternating current stimulation (tACS) through the utilization of the Miamind Neurostimulator in a cohort of healthy participants.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999916
Sponsor's protocol ID
BTN-100
Acronym
MindStim
Status last verified
Aug 2024
First submitted
3 Aug 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

    PubMed 28709880

  • Nissim NR, McAfee DC, Edwards S, Prato A, Lin JX, Lu Z, Coslett HB, Hamilton RH. Efficacy of Transcranial Alternating Current Stimulation in the Enhancement of Working Memory Performance in Healthy Adults: A Systematic Meta-Analysis. Neuromodulation. 2023 Jun;26(4):728-737. doi: 10.1016/j.neurom.2022.12.014. Epub 2023 Feb 8.

    PubMed 36759231

  • Menardi A, Rossi S, Koch G, Hampel H, Vergallo A, Nitsche MA, Stern Y, Borroni B, Cappa SF, Cotelli M, Ruffini G, El-Fakhri G, Rossini PM, Dickerson B, Antal A, Babiloni C, Lefaucheur JP, Dubois B, Deco G, Ziemann U, Pascual-Leone A, Santarnecchi E. Toward noninvasive brain stimulation 2.0 in Alzheimer's disease. Ageing Res Rev. 2022 Mar;75:101555. doi: 10.1016/j.arr.2021.101555. Epub 2021 Dec 30.

    PubMed 34973457

  • Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6.

    PubMed 35607946

  • Dhaynaut M, Sprugnoli G, Cappon D, Macone J, Sanchez JS, Normandin MD, Guehl NJ, Koch G, Paciorek R, Connor A, Press D, Johnson K, Pascual-Leone A, El Fakhri G, Santarnecchi E. Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer's Disease: A Case Series. J Alzheimers Dis. 2022;85(4):1667-1676. doi: 10.3233/JAD-215072.

    PubMed 34958021

  • Sprugnoli G, Munsch F, Cappon D, Paciorek R, Macone J, Connor A, El Fakhri G, Salvador R, Ruffini G, Donohoe K, Shafi MM, Press D, Alsop DC, Pascual Leone A, Santarnecchi E. Impact of multisession 40Hz tACS on hippocampal perfusion in patients with Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 20;13(1):203. doi: 10.1186/s13195-021-00922-4.

    PubMed 34930421

  • Joodaki M, Rodgers G, Hopf A, Koller MR, Guzman R, Santarnecchi E, Vogerl JS, Ferchow J, Ruffner A, Funken M, Meboldt M, Osmani B. A patient-specific, 3D printed neurostimulator enabling focal transcranial electrical stimulation and EEG at home. J Neuroeng Rehabil. 2025 Nov 24;22(1):248. doi: 10.1186/s12984-025-01769-8.

    PubMed 41287086

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Miamind Neurostimulator in people with Healthy Participants and Healthy Population, run by Bottneuro AG at 1 site in Switzerland.

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 7 inclusion and 11 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 6 Aug 2024. 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 Switzerland. 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?

Safety: Incidence of Treatment-Emergent Adverse Events (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05999916, which also lists 7 linked publications.

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 6 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in