Status:
COMPLETED
rTMS as a Treatment for PPA
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Logopenic Variant Primary Progressive Aphasia
Non-Fluent Primary Progressive Aphasia
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
Primary progressive aphasia (PPA) includes three variants. Two such variants, the non-fluent/agrammatic variant (nfvPPA) and the logopenic variant (lvPPA), are characterized by progressive word-findin...
Detailed Description
15-20 patients with a confirmed diagnosis of either nfvPPA or lvPPA (made by a specialized clinician) will be recruited. Patients must have a mild to moderate language impairment and must be native En...
Eligibility Criteria
Inclusion
- Patients, age 18-90, who carry a diagnosis of either the logopenic (lvPPA) or agrammatic non-fluent (nfvPPA) variants of Primary Progressive Aphasia (PPA). Patients must have been observed for at least one year by a specialized clinician.
- Patients must have at least mild to moderate language impairment.
- Patients must be native English speakers.
- Patients must have a study partner (e.g. spouse, sibling or adult child) who can accompany them to every study visit.
Exclusion
- Any history of seizures, unexplained loss of consciousness or a first-degree family member with epilepsy.
- Any history of significant co-occurring neurological illness unrelated to neurodegeneration associated with PPA (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 Diagnostic Statistical Manual (DSM-5) criteria.
- Magnetic Resonance Imaging (MRI) evidence of significant cerebrovascular disease, hydrocephalus or the presence of a space-occupying intra-cranial mass.
- Contraindications to MRI or repetitive transcranial magnetic stimulation (rTMS) including: cardiac pacemaker or pacemaker wires, neurostimulators, implanted pumps, metal in the body (rods, plates, screws, shrapnel, dentures, intrauterine device), surgical aneurysm clips in the head, previous neurosurgery or cochlear implants.
- In line with published Massachusetts General Hospital (MGH) Institutional Review Board (IRB) guidelines for rTMS, pregnancy must be ruled out by urine ß-Human Chorionic Gonadotropin 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 :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03406429
Start Date
December 1 2019
End Date
January 1 2022
Last Update
April 7 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129