Status:
COMPLETED
Network Modulation in Alzheimer's Disease
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Alzheimer Disease
Primary Progressive Aphasia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effects of non-invasive brain stimulation on memory and language ability in patients with two phenotypic variations of underlying Alzheimer disease pathology...
Detailed Description
Specific Aims Aim 1: To investigate the feasibility of selective rTMS modulation of the Default Mode Network (DMN) vs. language network in patients with aMCI and lvPPA. We will assess the reliability...
Eligibility Criteria
Inclusion
- Patients, age 18-90, who carry a diagnosis of either the logopenic variant (lvPPA) of PPA or amnestic MCI (aMCI). Patients must have been observed for at least one year by a specialized clinician.
- The presence of underlying AD pathology must be verified by a prior amyloid-PET and/or Tau-PET imaging (done as part of a prior protocol), or CSF biomarkers of AD pathology.
- Patients with lvPPA must have at least mild to moderate language impairment.
- Patients with aMCI must meet criteria for this condition, including the presence of at least mild to moderate episodic memory impairment.
- Patients must be native English speakers.
- Patients must have a study partner (e.g. spouse, sibling, adult child, friend) who can accompany them to all study visits.
Exclusion
- Any history of seizures, unexplained loss of consciousness or a first-degree family member with epilepsy (to ensure safety to receive rTMS).
- Any history of significant co-occurring neurological illness unrelated to the neurodegenerative disease in question (e.g. multiple sclerosis), or significant medical problems (e.g. poorly controlled diabetes/hypertension or cancer within 5 years).
- Active symptoms of major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or significant premorbid intellectual disability according to DSM criteria.
- MRI evidence of significant (e.g. confluent leukoariosis or stroke) cerebrovascular disease, hydrocephalus or the presence of a space-occupying intra-cranial mass.
- Contraindications to MRI or rTMS including: cardiac pacemaker or pacemaker wires, neurostimulators, implanted pumps, metal in the body (rods, plates, screws, shrapnel, dentures, IUD), surgical aneurysm clips in the head, previous neurosurgery or cochlear implants.
- In line with published MGH IRB guidelines for rTMS, pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04045990
Start Date
September 1 2018
End Date
March 1 2022
Last Update
March 17 2022
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129