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Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01179373
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Device: TMS, H coil Phase 2

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Actual Study Start Date : August 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TMS, High Frequency
High Frequency TMS with H coil to prefrontal cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Name: TransCranial Magnetic Stimulation

Active Comparator: TMS, Low Frequency
Low Frequency TMS to Prefrontal cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Name: TransCranial Magnetic Stimulation

Placebo Comparator: Sham Stimulation
Sham TMS with H Coil on Prefrontal Cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Name: TransCranial Magnetic Stimulation




Primary Outcome Measures :
  1. cognitive functioning score by ADAS-COG [ Time Frame: 4 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179373


Locations
Israel
Merchav Clinics
Tel Aviv, Israel
Sponsors and Collaborators
Brainsway

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01179373     History of Changes
Other Study ID Numbers: 10003
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders