Clinical trial NCT05842473: Long-term Effect of TMS in Primary Progressive Aphasia
Official title: Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Frontotemporal Dementia
Alzheimer Disease
Keywords: brain stimulation
transcranial magnetic stimulation
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are very few treatments for neurodegenerative disorders, and the efficacy of these treatments is generally modest. Recent studies have shown a short-term positive effect of non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) in primary progressive aphasia (PPA). PPA is a clinical syndrome associated with Alzheimer's disease and Frontotemporal degeneration. The aim of this study is to compare the effect of TMS and language therapy versus language therapy and sham TMS in patients with PPA during 6 months. A prospective, randomized, controlled, double-blind and parallel clinical trial will be conducted. The changes in brain metabolism using FDG-PET, language, neuropsychiatric symptoms, and daily-living activities will be assessed. Connectivity changes using electroencephalography will also be examined. In addition, a subgroup of patients will be assessed with multimodal MRI (structural and functional), and blood biomarkers. As a result of this project, valuable information about the long-term efficacy of non-invasive brain stimulation in PPA will be obtained, as well as the mechanisms of the therapy and clinical and neuroimaging factors associated with therapy response.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PPA (Gorno-Tempini et al. 2011 criteria supported by neuroimaging)
* CDR
* Language is the most prominent symptom

Exclusion Criteria:

* Clinical Dementia Rating scale \> 1
* History of epilepsy or epileptiform activity in EEG
* Another disorder causing aphasia
* Any contraindication for TMS
* Pregnancy
* Medical disorder with a life expectancy of less than one year
* Malignancy in the last two years
* Alcohol or drug abuse
* Major psychiatric disorder
* Inability to communicate (mutism)
* Use of anticonvulsants, benzodiazepines, donepezil/galantamine/rivastigmine, memantine, antidepressants and neuroleptics is permitted if they are at stable doses in the last three months.

Primary outcomes:
measure: Brain Metabolism
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Spontaneous language
timeFrame: 0, 3 and 6 months
measure: Language assessment (Mini-Linguistic State Examination)
timeFrame: 0, 3 and 6 months
measure: Language assessment (trained words)
timeFrame: 0, 3 and 6 months
measure: Daily-living activities
timeFrame: 0, 3 and 6 months
measure: Neuropsychiatric symptoms
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos.
Study officials:
affiliation: Hospital Clinico San Carlos
name: Jordi A Matias-Guiu, PhD
role: PRINCIPAL_INVESTIGATOR
References: