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

NCT05999916 | Completed

• 1 other identifier: BTN-100
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants; Healthy Population

Keywords

Alzheimer Disease; tACS; Memory Problems; Cognitive Impairment; Cognitive Performance; Safety and Tolerability; Feasibility

Outcome Measures

Primary Outcomes (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.

  up to 2 weeks

Secondary Outcomes (5)

• Safety and comfort: questionnaire

  up to 2 weeks

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

  up to 2 weeks

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

  up to 2 weeks

• Cognitive Evaluation: Montreal Cognitive Assessment (MoCA)

  up to 2 weeks

• Participant coherence and satisfaction questionnaire

  up to 2 weeks

Study Arms (1)

60 min session of 40Hz tACS by Miamind Neurostimulator

EXPERIMENTAL

The 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).

Device: Personalized Miamind Neurostimulator

Interventions

Personalized Miamind Neurostimulator DEVICE

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).

60 min session of 40Hz tACS by Miamind Neurostimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Bottneuro AG: lead
• Hemex AG: collaborator

Study Sites (1)

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 28709880 BACKGROUND

• 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.

  PMID: 36759231 BACKGROUND

• 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.

  PMID: 34973457 BACKGROUND

• 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.

  PMID: 35607946 BACKGROUND

• 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.

  PMID: 34958021 BACKGROUND

• 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.

  PMID: 34930421 BACKGROUND

• 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.

  PMID: 41287086 DERIVED

Related Links

• Bottneuro Website

MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Officials

• Alois Hopf, PhD

  Bottneuro AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: December 27, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CH (1)