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OpenTrials
Completed

NCT Number: NCT01179373

Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

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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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Merchav Clinics

Tel Aviv, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 50-85.
  • Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
  • Scored below 24 on the MMSE.
  • 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.
  • Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
  • Gave their oral and written consent to participate in the trial.

Exclusion criteria

  • An additional neurological or psychiatric disorder.
  • Severe personality disorder.
  • Uncontrolled hypertension.
  • History of epilepsy, seizure, or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of head injury or stroke.
  • History of metal implants in the head (except dental fillings).
  • 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.
  • History of migraines in the last six months.
  • History of drug or alcohol abuse.
  • Inadequate communication with examiner.
  • Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
  • Inability to sign a consent form.

Treatment and study plan

TMS, H coil

Device

TMS, H Coil, High/ Low Frequency

Other names: TransCranial Magnetic Stimulation

Primary outcomes

  1. cognitive functioning score by ADAS-COG

    Time frame: 4 months

Secondary outcomes

  1. Global advancement score by CGI-C

    Time frame: 4 months

  2. Frontal lobe functioning score by FAB

    Time frame: 4 months

  3. Daily activity score by ADL

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Brainsway

Industry

Registry information

Official study title

Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2010
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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