NCT01464515

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

October 25, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
9.2 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 14, 2020

Status Verified

January 1, 2020

Enrollment Period

Same day

First QC Date

October 25, 2011

Last Update Submit

July 13, 2020

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, So StatedDeep Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Mindstreams

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

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

Secondary Outcomes (1)

  • CDR - Clinical Dementia Rating

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

Study Arms (2)

Real TMS

ACTIVE COMPARATOR

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

Device: H-Coil Deep TMS

SHAM TMS

SHAM COMPARATOR

this group will receive SHAM treatment of deep TMS

Device: SHAM Coil TMS

Interventions

H-Coil Deep TMSDEVICE

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

Real TMS
SHAM Coil TMSDEVICE

this group will receive SHAM treatment of deep TMS

SHAM TMS

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 50-80 years of age.
  • Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
  • 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)
  • score \>= 24 in MMSE (Mini Mental State Examination) test.
  • Preserved Cognitive and executive functioning, without dementia according to DSM -IV
  • Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
  • 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.
  • Capable and willing to provide informed consent.

You may not qualify if:

  • Any other Axis I diagnosis as the primary diagnosis
  • Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
  • History of non tolerance for TMS treatment
  • Diagnosis of Severe personality disorder according to DSM-IV
  • current suicidal tendency
  • 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 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ichilov Hospital, Neurological Department

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Elissa Ash, Dr.

    Ichilov Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellisa Ash, Dr.

CONTACT

+97236973698elissaa@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 3, 2011

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 14, 2020

Record last verified: 2020-01

Locations

IL(1)