NCT01334450

Brief Summary

Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 alzheimer-disease

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 2, 2023

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 12, 2011

Last Update Submit

February 28, 2023

Conditions

Keywords

Improvement of ADAS-COG

Outcome Measures

Primary Outcomes (1)

  • cognitive functioning score by ADAS-COG

    4 months

Study Arms (3)

High Frequency TMS to prefrontal cortex

ACTIVE COMPARATOR
Device: TMS , H2-coil

Low Frequency TMS to Prefrontal cortex

ACTIVE COMPARATOR
Device: TMS , H2-coil

Sham TMS on Prefrontal Cortex

SHAM COMPARATOR
Device: TMS , H2-coil

Interventions

Trans cranial magnetic stimulation with H2-coil

Also known as: Not relevant
High Frequency TMS to prefrontal cortexLow Frequency TMS to Prefrontal cortexSham TMS on Prefrontal Cortex

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Zeev Meiner, Dr.

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

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

Locations