Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753662

Acronym

TMS in AD

Enrollment

Registered

2008-09-16

Start date

2008-11-30

Completion date

2012-11-30

Last updated

2011-09-13

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

Conditions

Alzheimer's Disease

Keywords

TMS AD H2 coil

Brief summary

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Detailed description

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17). Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm. Ages: 50-80 Genders: both

Interventions

DEVICE1Hz TMS with H2 coil

1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

DEVICE10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

DEVICESHAM TMS with H2 coil

SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Written informed consent will be obtained * diagnostic evidence of probable AD consistent with DSM IV * stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening * stable dose treatment with other drugs * MMSE \<25

Exclusion criteria

* Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD * Patients who are unwilling or unable to fulfill the requirements of the study * Severe personality disorder * Malignant or untreated Hypertension * History of Epilepsy * History of Head trauma * Metal implant in head, cardiac pacemaker, medical pump * Drug or alcohol addiction * Involvement in any other clinical trial during the preceding 3 month * Patient who are unwilling or unable to give Informed Consent

Design outcomes

Primary

Measure	Time frame
ADAS-COG	Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Secondary

Measure	Time frame
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.	Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Countries

Israel

Contacts

Primary ContactAlissa Ash, Dr.

elissaa@tasmc.health.gov.il+972-3-6973698

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026