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Development of a Novel Transcranial Magnetic Stimulation Therapy for Mild Cognitive Impairment

An Open-Label Feasibility Study for the Development of Intensified Accelerated Deep Intermittent Theta Burst Stimulation Therapy in Mild Cognitive Impairment - Advanced optimized neuromodulation therapy for MCI (ADON-MCI)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250381
Enrollment
28
Registered
2025-09-22
Start date
2025-09-22
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 Cognitive dysfunction, Memory loss, Amnesia, Dementia, Alzheimers disease

Interventions

Sponsors

Osawa Ryota
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Individuals aged between 50 and 85 years at the time of consent acquisition. 2) Individuals with an MMSE score of 22 or above. 3) Individuals with a CDR score of 0.5 or 1.0. 4) Individuals with confirmed accumulation of amyloid beta through amyloid PET imaging. 5) Individuals who are eligible for anti-amyloid-beta antibody therapy but did not wish to receive the treatment. 6) Individuals for whom anti-amyloid-beta antibody therapy is difficult to apply due to medical reasons such as contraindications. 7) Individuals deemed capable of providing written consent by their attending physician. 8) Individuals able to attend outpatient visits for TMS treatment.

Exclusion criteria

Exclusion criteria: 1) Individuals with organic brain diseases (moderate or severe intracranial structural lesions). 2) Individuals with a history of seizures or epilepsy. 3) Individuals with unstable physical conditions (e.g., heart failure or renal failure). 4) Individuals with mental instability severe enough to hinder outpatient visits. 5) Individuals with contraindications to TMS, such as metal implants in the head or neck or a cardiac pacemaker. 6) Individuals deemed unsuitable for participation in the study by the principal investigator or co-investigators.

Design outcomes

Primary

MeasureTime frame
Changes in CDR-SB score before and after the novel TMS treatment

Secondary

MeasureTime frame
Change in the following items before and after the novel TMS therapeutic intervention - MMSE - DASC-21 - TMT

Contacts

Public ContactYoshihiro Noda

International University of Health and Welfare

yoshi-tms@ihwg.jp+81-3-3451-8121

Outcome results

None listed

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