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

JRCT ID: jRCT1012240018

Registered date:19/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: mild cognitive impairment
• Date of first enrollment: 19/06/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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 not displaced. During stimulation, the patient can use the toilet, eat and sleep, and there are no restrictions on behaviour or position. Stimulation is applied to the auricle with a sticker for 1 hour once a day at 1.5 mA, 25 Hz for 250 us. Stimulation is based on 1.5 mA, 25 Hz for 250 us, but habituation may occur, in which case the researcher should check and adjust the stimulation frequency between 1 and 20 mA, 2 and 100 Hz, aiming for crackling but not pain. Adjustments are made.

Outcome(s)

• Primary Outcome: Change in Clinical Dementia Rating Scale (CDR-SB score) from study entry to 52 weeks.

Secondary Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Include criteria: Patients with MCI attending or being admitted to Hokkaido University Hospital between the date of implementation approval and 31 January 2028.

Exclude 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.

Related Information

• Primary Sponsor: Yabe Ichiro