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Transcranial magnetic stimulation (TMS) to slow down cognitive decline in Alzheimer*s disease (AD): TMSLA - a monocentric randomized controlled trial.

Transcranial magnetic stimulation (TMS) to slow down cognitive decline in Alzheimer*s disease (AD): TMSLA - a monocentric randomized controlled trial. - TMSLA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57241
Enrollment
55
Registered
2024-09-04
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Alzheimers disease dementia

Interventions

32 sessions of 20 Hz rTMS over the precuneus: a 2-week intensive phase with daily (5x/week) rTMS, followed by a 22-week maintenance phase with weekly rTMS.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Biomarker-supported Alzheimer*s disease (Abnormal CSF p-tau/Aß42 ratio of >  0.023 or Amyloid PET positive). - Between 50 and 85 years old.  - Clinical dementia rating (CDR) score of 0.5 or 1 {Morris, 1993 #80}. - Mini-mental state examination (MMSE) score between 18 and 27.  - Presence of a caregiver.

Exclusion criteria

Exclusion criteria: - Medical history of other neurodegenerative diseases, stroke, or epilepsy. - Severe psychiatric dysregulation, hampering successful study participation and leading to possible cognitive impairment. Eligibility for participation will be based on clinical evaluation by an expert neurologist and/or psychiatrist. - Extensive cerebrovascular damage on MRI classified as Fazekas level 2 or 3. Patients with abnormalities classified as Fazekas level 3 are excluded {Fazekas F Fau - Chawluk, #115}. For Fazekas level 2, patient*s eligibility for participation will be evaluated by an expert neurologist. - Presence of metal in the head or cranial/thoracic implants, including cochlear implants. - Cholinesterase inhibitors with unstable d osage in the last 2 months. - Extreme claustrophobia or metallic objects in or on the body, preventing MRI and MEG examination. - Previous rTMS treatment (for blinding reasons).

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the pre-to-post difference in clinical dementia rating, as measured with the clinical dementia rating - sum of boxes scale (CDR-SB), in the real rTMS condition compared to the sham condition.

Secondary

MeasureTime frame
Secondary outcome measures include additional cognitive and clinical rating scales, neuropsychological assessment batteries, magnetoencephalography, and cerebrospinal fluid biomarkers.

Countries

Netherlands

Contacts

Public ContactHJ Woerdman

Amsterdam UMC

h.j.woerdman@amsterdamumc.nl020 - 444 8548

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)