Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

15 patients in group 1 will be treated with 1Hz frequency

Group Type ACTIVE_COMPARATOR

1Hz TMS with H2 coil

Intervention Type DEVICE

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

2

15 patients in group 2 will be treated with 1Hz frequency 10Hz

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

3

15 patients in group 3 will be treated with SHAM (1Hz/10Hz)

Group Type SHAM_COMPARATOR

SHAM TMS with H2 coil

Intervention Type DEVICE

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

Interventions

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1Hz TMS with H2 coil

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

Intervention Type DEVICE

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

Intervention Type DEVICE

SHAM TMS with H2 coil

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

Intervention Type DEVICE

Other Intervention Names

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10Hz TMS with H2 coil

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No