Primary Progressive Nonfluent Aphasia Clinical Trial
Official title:
A Randomized, Double-blinded, Sham-controlled Cross-over Study of Theta-burst Transcranial Magnetic Stimulation in Nonfluent/Agrammatic Variant Primary Progressive Aphasia
Verified date | February 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nonfluent/agrammatic variant primary progressive aphasia (nf/avPPA) is a fatal neurodegenerative disease that begins with isolated language deficits. There is currently no cure or treatment for this disease. Repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive neuromodulatory technique, is effective in major depression, and studied in many other conditions including nf/avPPA. Here the investigators propose to study the feasibility and change in language and brain function of a newer rTMS protocol (intermittent theta-burst stimulation, iTBS) using a randomized, blinded crossover design: participants will receive active or sham iTBS for two weeks and then switch groups without them or clinicians knowing their group. The investigators hypothesize that brain function and performance with language tasks will change after active iTBS.
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 14, 2022 |
Est. primary completion date | February 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Clinically diagnosed with nonfluent-agrammatic variant primary progressive aphasia (nfvPPA), by 2011 Gorno-Tempini diagnostic criteria. - Frontotemporal lobar degeneration modified clinical dementia rating scale (FTLD-CDR) score =4 (mild). - Is voluntary and competent to consent to treatment, or if demented, to assent and co-consent can be obtained by their legal next-of-kin, legal guardian, or substitute decision maker. - Speaks English enough to be able to complete neuropsychological testing. - Able to adhere to the treatment schedule. - Has a study partner available to answer the Progressive Aphasia Severity Scale (PASS) questionnaire. Exclusion Criteria: - Uncorrected visual or hearing impairment by self report. - History of substance dependence or abuse within the last 3 months. - Has active suicidal intent. - Has a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of major depressive disorder, bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms. - Concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump. - Any significant neurological disorder other than nfvPPA including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of epilepsy, known cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes in the previous 6 months. - Is currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent) or any dose of an anticonvulsant, due to the potential to limit rTMS efficacy. Exclusion Criteria for TMS Participation: - Does not pass the TMS adult safety screening (TASS) questionnaire (e.g. has an intracranial implant) Exclusion Criteria for MRI Participation: - Severe claustrophobia. - Cardiac pacemakers or ferromagnetic implants. - Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Canada | Non-Invasive Neurostimulation Therapies lab, University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events | Safety will be measured by incidence of treatment-emergent adverse events | 6 weeks | |
Primary | Tolerability levels according to the daily Comfort Rating Questionnaire (CRQ) | Tolerability will be measured by daily Comfort Rating Questionnaire (CRQ) between sham and active interventions and compared using Chi-square. A mean score across all treatment sessions above 6 on more than 2 items on the CRQ will be considered as severe. A mean score across all treatment sessions between 4 and 6 on more than 2 items on the CRQ will be considered as moderate tolerability. A mean score across all treatment sessions below 4 on the majority of items will be considered as mild tolerability. | 6 weeks | |
Primary | Drop out rate | Feasibility will be measured by drop out rate. A drop out rate >50% will be considered as an indication of non-feasibility of current protocol. | 6 weeks | |
Secondary | Changes in the Verb and Object Naming Test score | Verb and Object Naming Test score at baseline and at 2, 4, and 6 weeks | 6 weeks | |
Secondary | Changes in the Make a Sentence Test score | Make a Sentence Test score at baseline and at 2, 4, and 6 weeks | 6 weeks | |
Secondary | Changes in the Sentence Comprehension Test score | Sentence Comprehension Test score at baseline and at 2, 4, and 6 weeks | 6 weeks | |
Secondary | Changes in the Apraxia of Speech Rating Scale score | Apraxia of Speech Rating Scale score at baseline and at 6 weeks | 6 weeks | |
Secondary | Changes in the Clinical Global Impression of Change score | Clinical Global Impression of Change score at baseline and at 2, 4, and 6 weeks | 6 weeks | |
Secondary | Changes in the Progressive Aphasia Severity Scale rating | Progressive Aphasia Severity Scale rating at baseline and at 6 weeks | 6 weeks | |
Secondary | Changes in the Western Aphasia Battery rating | Western Aphasia Battery rating at baseline and at 6 weeks | 6 weeks | |
Secondary | Changes in the Montreal Cognitive Assessment Battery score | Montreal Cognitive Assessment Battery score at baseline and at 6 weeks | 6 weeks | |
Secondary | Changes in the Frontal Assessment Battery score | Frontal Assessment Battery score at baseline and at 6 weeks | 6 weeks | |
Secondary | Changes in the whole-brain functional connectivity measured using functional Magnetic Resonance Imaging (MRI) | fMRI at baseline and at 2 and 6 weeks | 6 weeks | |
Secondary | Changes in the brain cortical blood oxygenation measured using functional Near Infrared Spectroscopy (fNIRS) | fNIRS at baseline and at 2, 4, and 6 weeks | 6 weeks | |
Secondary | Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG) | EEG at baseline and at 2, 4, and 6 weeks | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01623284 -
PiB PET Scanning in Speech and Language Based Dementias
|
Phase 1 | |
Active, not recruiting |
NCT03174886 -
A 24-month Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia
|
Phase 1 | |
Withdrawn |
NCT04883229 -
tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study
|
N/A | |
Recruiting |
NCT03313011 -
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
|