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Completed

NCT Number: NCT05842473

Long-term Effect of TMS in Primary Progressive Aphasia

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.

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Key information

Conditions

Primary Progressive Aphasia Alzheimer Disease Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Language Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Speech Disorders TDP-43 Proteinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico San Carlos.

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (active)

Device

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

Behavioral

Language therapy immediately after each TMS session. Daily sessions for two weeks followed by 1 session per week.

Transcranial Magnetic Stimulation (sham)

Device

Theta-burst transcranial magnetic stimulation (sham) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.

Primary outcomes

  1. Brain Metabolism

    Time frame: 0 and 6 months

    Changes in FDG-PET imaging (Standard Uptake Value ratio)

Secondary outcomes

  1. Spontaneous language

    Time frame: 0, 3 and 6 months

    Changes in Words per minute

  2. Language assessment (Mini-Linguistic State Examination)

    Time frame: 0, 3 and 6 months

    Changes in Mini-Linguistic State Examination test

  3. Language assessment (trained words)

    Time frame: 0, 3 and 6 months

    Changes in trained words accuracy (number of words)

  4. Daily-living activities

    Time frame: 0, 3 and 6 months

    Changes in Interview for Deterioration in Daily living in Dementia Scale

  5. Neuropsychiatric symptoms

    Time frame: 0, 3 and 6 months

    Changes in Neuropsychiatric Inventory scale

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Acronym: RECONNECT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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