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TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294888
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica A. Collins, PhD, Massachusetts General Hospital

Brief Summary:

The purpose of this study is to assess the effects of non-invasive brain stimulation on memory in cognitively unimpaired older adults and in patients amnestic mild cognitive impairment (aMCI) due to Alzheimer's disease (AD). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of the Default Mode Network (DMN)- which is thought to support episodic memory and to be affected by Alzheimer's pathology.

We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth memory testing.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment Aging Device: repetitive transcranial magnetic stimulation (rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will each undergo, in a crossover, within-subject design, two blocks of rTMS: active and SHAM.The order of active and SHAM blocks will be counterbalanced across subjects.
Masking: Single (Participant)
Masking Description: All participants will undergo SHAM stimulation as a control condition. They will be blinded as to whether they are receiving active or SHAM stimulation.
Primary Purpose: Treatment
Official Title: TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Active stimulation
Active rTMS will be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). Active rTMS will be delivered at 80% of a patient's active motor threshold. rTMS will be administered in an excitatory iTBS pattern. Stimulation parameters will remain well within established safety guidelines (Rossi et al. 2009).
Device: repetitive transcranial magnetic stimulation (rTMS)
rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.

Sham Comparator: Sham stimulation
SHAM stimulation will also be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). SHAM rTMS will be delivered at 80% of a patient's active motor threshold. SHAM stimulation will be delivered to the exact same cortical targets as active rTMS. While no electromagnetic stimulation will be delivered during SHAM, the sounds will approximate active stimulation and skin electrodes will approximate the sensation of active rTMS. Inclusion of a sham condition in this protocol is critical to measure whether or not the stimulation is improving memory performance, or whether practice effects or other non-specific effects are responsible for any changes in memory which may be observed.
Device: repetitive transcranial magnetic stimulation (rTMS)
rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.




Primary Outcome Measures :
  1. Paired Associative Face Name Memory Test [ Time Frame: up to 5 weeks ]
    A test of memory for face-name associations


Secondary Outcome Measures :
  1. Changes in intrinsic functional connectivity [ Time Frame: up to 5 weeks ]
    Changes in region-to-region functional connectivity within the stimulated network will be assessed



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between the ages of 60-85
  2. All participants will be native English speakers
  3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
  4. Participants with aMCI will be asked to bring a study partner to all visits
  5. Only patients with very mild or mild cognitive impairment (CDR 0.5 or CDR 1) will be included in the prodromal AD cohort

Exclusion Criteria:

  1. History of head trauma involving loss of consciousness or alteration in consciousness
  2. Another major neurologic or psychiatric condition
  3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
  4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
  5. Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
  6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
  7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging

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): NCT04294888


Contacts
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Contact: Jessica A Collins, PhD 617-726-6217 jcollins21@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachuetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Courtney Sullivan    617-643-5568    csullivan65@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
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Responsible Party: Jessica A. Collins, PhD, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04294888    
Other Study ID Numbers: 2019P003445
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with researchers outside of this protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders