Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Repetitive Transcranial Magnetic Stimulation for Dementia (rTMS for demen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621424
Recruitment Status : Active, not recruiting
First Posted : December 3, 2015
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.

Condition or disease Intervention/treatment Phase
Dementia Mild Cognitive Impairment Device: RTMS Device: sham Not Applicable

Detailed Description:

The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:

  • 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that
  • 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for Dementia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 28, 2018
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: RTMS
repetitive transcranial magnetic stimulation
Device: RTMS
stimulation of the brain with magnetic pulses

Sham Comparator: sham
sham noise to block the sound of treatment
Device: sham
sham noise to block the sound of stimulation




Primary Outcome Measures :
  1. changes from baseline CVLT scores after treatment and 4 months later [ Time Frame: within a week following the final treatment session and 4 month later ]
    California visual learning test- memory, executive


Secondary Outcome Measures :
  1. changes in Boston Naming after treatment and 4 months later [ Time Frame: within a week following the last treatment session and 4 months later ]
    Boston Naming

  2. changes in BDNF levels in serum and/or CSF after treatment and 4 months later [ Time Frame: within a week following the last treatment session and 4 months later ]
    BDNF levels in serum and/or CSF

  3. changes in Animal fluency after treatment and 4 months later [ Time Frame: immediately following treatment and 4 months later ]
    Animal fluency

  4. changes in Trail making after treatment and 4 months later [ Time Frame: immediately following treatment and 4 months later ]
    Trail making



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans aged 55 years or older
  • Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease.
  • Ability to obtain a Motor Threshold, determined during the screening process.
  • With an adequately stable condition and living environment to enable attendance at scheduled clinic visits.
  • If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase.
  • Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments.

Exclusion Criteria:

  • Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).
  • Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures.
  • Have a cardiac pacemaker or a cochlear implant.
  • Have an implanted device deep brain stimulation or metal in the brain
  • Current substance abuse not including caffeine or nicotine as determined by patient report or chart review.
  • Active current suicidal intent or plan as determined by patient report or chart review.
  • Current or Prior history of a seizure disorder as determined by patient report or chart review
  • Traumatic brain injury within the last two months
  • Participation in another concurrent interventional clinical trial
  • Known current psychosis as determined by patient report or chart review.
  • Current or prior history of a mass lesion, cerebral infarct or other non-cogitative, active central nervous system (CNS) disease that would increase the risk for seizure.
  • Not fluent in English or a hearing impairment severe enough to impair comprehension

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): NCT02621424


Locations
Layout table for location information
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Jauhtai J Cheng, MD VA Palo Alto Health Care System, Palo Alto, CA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02621424     History of Changes
Other Study ID Numbers: E1889-P
RX14-009 ( Other Grant/Funding Number: VA )
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Each participant will be informed of their treatment arm (sham versus actual RTMS) at the end of study.

The participant is then given the option of receiving actual treatment if a sham treatment was used for this participant during the study.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
dementia
Mild Cognitive Impairment (MCI)
RTMS
CVLT

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders