Deep Transcranial Magnetic Stimulation for Treatment of 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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-06-30

Brief Summary

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The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, 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,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Ages: 50-85 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

DOUBLE

Participants Caregivers

Study Groups

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TMS, High Frequency

High Frequency TMS with H coil to prefrontal cortex

Group Type ACTIVE_COMPARATOR

TMS, H coil

Intervention Type DEVICE

TMS, H Coil, High/ Low Frequency

TMS, Low Frequency

Low Frequency TMS to Prefrontal cortex

Group Type ACTIVE_COMPARATOR

TMS, H coil

Intervention Type DEVICE

TMS, H Coil, High/ Low Frequency

Sham Stimulation

Sham TMS with H Coil on Prefrontal Cortex

Group Type PLACEBO_COMPARATOR

TMS, H coil

Intervention Type DEVICE

TMS, H Coil, High/ Low Frequency

Interventions

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TMS, H coil

TMS, H Coil, High/ Low Frequency

Intervention Type DEVICE

Other Intervention Names

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TransCranial Magnetic Stimulation

Eligibility Criteria

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Inclusion Criteria

1. Men and women aged 50-85.
2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
3. Scored below 24 on the MMSE.
4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
6. Gave their oral and written consent to participate in the trial.

Exclusion Criteria

1. An additional neurological or psychiatric disorder.
2. Severe personality disorder.
3. Uncontrolled hypertension.
4. History of epilepsy, seizure, or heat convulsion.
5. History of epilepsy or seizure in first degree relatives.
6. History of head injury or stroke.
7. History of metal implants in the head (except dental fillings).
8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.
9. History of migraines in the last six months.
10. History of drug or alcohol abuse.
11. Inadequate communication with examiner.
12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
13. Inability to sign a consent form.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No