Exploratory clinical trial of low frequency therapy for mild cognitive impairment.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1012240018

Enrollment

Registered

2024-06-19

Start date

2024-06-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment

Interventions

Low-frequency therapy equipment is administered. Bathing should be avoided during stimulation and the patient should be allowed to walk and move around, but only to the extent that the electrodes are

Eligibility

Inclusion criteria

Inclusion criteria: Patients with MCI attending or being admitted to Hokkaido University Hospital between the date of implementation approval and 31 January 2028.

Exclusion criteria

Exclusion criteria: Patients who fall into any one of the following categories should be excluded from inclusion. (i) Those with a history of progressive brain lesions. (ii) Patients receiving concomitant vagus nerve stimulation therapy (iii) Patients with a history of severe cardiovascular disease (iv) Pregnant or lactating women (v) Persons with skin hypersensitivity and a history of skin symptoms caused by metals, etc. (vi) Persons with difficulty in oral intake (vii) Persons with severe renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 mL/min) (viii) Persons with a cardiac pacemaker or implantable cardioverter-defibrillator. (ix) Persons who have used or plan to use RECANEMAB. (x) Other persons who are deemed inappropriate as research subjects by the principal investigator or research assistant.

Design outcomes

Primary

Measure	Time frame
Change in Clinical Dementia Rating Scale (CDR-SB score) from study entry to 52 weeks.	—

Secondary

Measure	Time frame
(i) Safety in the implementation of infrasound therapy and whether or not adverse events have occurred. (ii) Changes in ADAS-cog14 and ADCOMS before and after low-frequency treatment (iii) The localisation of immune cells before and after infrasound treatment, the positive expression of a group of molecules whose expression is induced by inflammation, the intensity of expression, and the presence or absence of disease-related gene variants and their association with the pathological condition. Correlations between the state of inflammation and the expression status of other analysed molecules.	—

Measure

Time frame

(i) Safety in the implementation of infrasound therapy and whether or not adverse events have occurred. (ii) Changes in ADAS-cog14 and ADCOMS before and after low-frequency treatment (iii) The localisation of immune cells before and after infrasound treatment, the positive expression of a group of molecules whose expression is induced by inflammation, the intensity of expression, and the presence or absence of disease-related gene variants and their association with the pathological condition. Correlations between the state of inflammation and the expression status of other analysed molecules.

—

Contacts

Public Contactichiro yabe

Hokkaido University Hospital

yabe@med.hokudai.ac.jp+81-117161161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026