Long-term Effect of TMS in Primary Progressive Aphasia
RECONNECT
Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedDecember 18, 2024
December 1, 2024
1.5 years
April 24, 2023
December 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain Metabolism
Changes in FDG-PET imaging (Standard Uptake Value ratio)
0 and 6 months
Secondary Outcomes (5)
Spontaneous language
0, 3 and 6 months
Language assessment (Mini-Linguistic State Examination)
0, 3 and 6 months
Language assessment (trained words)
0, 3 and 6 months
Daily-living activities
0, 3 and 6 months
Neuropsychiatric symptoms
0, 3 and 6 months
Study Arms (2)
TMS active + language therapy
ACTIVE COMPARATORTMS (active) using theta burst protocol over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by one session per week during 6 months. Each TMS session is followed by language training.
TMS sham + language therapy
SHAM COMPARATORTMS (sham) using theta burst protocol over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by one session per week during 6 months. Each TMS session is followed by language training.
Interventions
Theta-burst transcranial magnetic stimulation (active) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.
Language therapy immediately after each TMS session. Daily sessions for two weeks followed by 1 session per week.
Theta-burst transcranial magnetic stimulation (sham) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.
Eligibility Criteria
You may qualify if:
- Diagnosis of PPA (Gorno-Tempini et al. 2011 criteria supported by neuroimaging)
- CDR
- Language is the most prominent symptom
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital ClĂnico San Carlos.
Madrid, Madrid, 28040, Spain
Related Publications (1)
Fernandez-Romero L, Cabrera-Martin MN, Delgado-Alonso C, Suarez-Coalla P, Grasso SM, Portoles A, Perez-Macias N, Carreras MT, Diez-Cirarda M, Gil-Moreno MJ, Olazaran J, Vieira A, Oliver-Mas S, Gomez-Pinedo U, Matias-Guiu J, Matias-Guiu JA. Long-Term Therapy With Transcranial Magnetic Stimulation in Primary Progressive Aphasia: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526129. doi: 10.1001/jamanetworkopen.2025.26129.
PMID: 40788648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordi A Matias-Guiu, PhD
Hospital Clinico San Carlos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 6, 2023
Study Start
February 1, 2023
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
December 18, 2024
Record last verified: 2024-12