Transcranial Magnetic Stimulation (TMS) Treatment for Alzheimer Patients
Deep-TMS for the Treatment of Alzheimer Disease Patients
1 other identifier
interventional
10
1 country
1
Brief Summary
Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 alzheimer-disease
Started Jun 2011
Shorter than P25 for phase_2 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 2, 2023
April 1, 2011
1 year
April 12, 2011
February 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cognitive functioning score by ADAS-COG
4 months
Study Arms (3)
High Frequency TMS to prefrontal cortex
ACTIVE COMPARATORLow Frequency TMS to Prefrontal cortex
ACTIVE COMPARATORSham TMS on Prefrontal Cortex
SHAM COMPARATORInterventions
Trans cranial magnetic stimulation with H2-coil
Eligibility Criteria
You may qualify if:
- Men and women aged 50-85.
- Diagnosed with Alzheimer's disease for at least half a year (by the DSM-IV criteria).
- Scored between 16-26 on the MMSE.
- Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks.
- Existence of a routine therapist for changes or adverse effects reports.
- Existence of Alzheimer diagnosis by CT or MRI tests.
- 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.
You may not qualify if:
- An additional neurological disorder.
- Severe psychiatric disorder.
- Uncontrolled hypertension, beyond 170/110.
- History of epilepsy, seizure, or heat convulsion or 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)or 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Center
Jerusalem District, Israel, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeev Meiner, Dr.
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 2, 2023
Record last verified: 2011-04