CClinicalTrials.gg
Status unknownNCT01464515Updated Jul 14, 2020

Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment

A Phase 1 interventional study of H-Coil Deep TMS and SHAM Coil TMS in Mild Cognitive Impairment, sponsored by Brainsway. Status unknown at 1 site in Israel. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Brainsway · Phase 1, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
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Study summary

This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.

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Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Mild Cognitive Impairment, So Stated
  • Deep Transcranial Magnetic Stimulation
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 30 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Brainsway is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men and women 50-80 years of age.
  2. Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
  3. Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
  4. score >= 24 in MMSE (Mini Mental State Examination) test.
  5. Preserved Cognitive and executive functioning, without dementia according to DSM -IV
  6. Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
  7. Score of maximum 0.5 in the Clinical Dementia Rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test.
  8. Capable and willing to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Any other Axis I diagnosis as the primary diagnosis
  2. Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
  3. History of non tolerance for TMS treatment
  4. Diagnosis of Severe personality disorder according to DSM-IV
  5. current suicidal tendency
  6. Uncontrolled hypertension
  7. History of epilepsy, seizure, or heat convulsion
  8. History of epilepsy or seizure in first degree relatives
  9. History of head injury or stroke
  10. History of metal implants in the head (except dental fillings)
  11. 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
  12. History of drug or alcohol abuse
  13. Inadequate communication with examiner
  14. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
  15. Inability to sign a consent form
  16. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
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Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Real TMS

    this group will receive high frequency deep TMS treatment of 10HZ

    Device: H-Coil Deep TMS

  • Sham comparator
    SHAM TMS

    this group will receive SHAM treatment of deep TMS

    Device: SHAM Coil TMS

Interventions

  • DeviceH-Coil Deep TMS

    this group will receive high frequency treatment of deep TMS with 10Hz

  • DeviceSHAM Coil TMS

    this group will receive SHAM treatment of deep TMS

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What researchers measure

Primary outcomes

  1. Mindstreams

    Mindstreams test is designed to test the I.Q change of the patients from baseline

    Time frame: the test will be assessed on visit 17 which means 4 month from baseline

Secondary outcomes

  1. CDR - Clinical Dementia Rating

    CDR test is designed to test the dementia severity of the patients from baseline

    Time frame: the test will be assessed on visit 17 which means 4 month from baseline

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01464515
Lead sponsor
Brainsway
Responsible party
Sponsor
First posted
Nov 3, 2011
Start date
Jan 2021 (estimated)
Primary completion
Jan 2021 (estimated)
Completion
Jan 2021 (estimated)
Last update
Jul 14, 2020

Study contacts

Ellisa Ash, Dr.
Contact
elissaa@tasmc.health.gov.il
+97236973698
Elissa Ash, Dr.
principal investigator · Ichilov Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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