Long Term Effect of Brain Stimulation in PPA

Официальное название

Long-term Effect of Transcranial Magnetic Stimulation and Transcranial Electrical Stimulation in Primary Progressive Aphasia: Randomized, Double-blind Clinical Trial (RECONNECT-PLUS)

Обзор

The goal of this clinical trial is to investigate the effect of non-invasive brain stimulation techniques in the progression of primary progressive aphasia for 6 months. We will compare three modalities of brain stimulation (TMS, tDCS, TMS+tDCS) against sham stimulation. All patients will receive also language therapy.

Подробное описание

Transcranial Magnetic Stimulation will follow an intermitent theta-burst protocol targetting the left dorsolateral prefrontal cortex. Transcranial electrical stimulation will also follow an excitatory protocol over the same region. All brain stimulation procedures will be conducted under neuronavigation. Language therapy will follow the lexical retrieval cascade protocol and will be conducted after each brain stimulation session.

Вмешательства

• Устройство TMS
  Active TMS + sham tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)
• Устройство tDCS
  sham TMS + active tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)
• Устройство Sham TMS
  Sham TMS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)
• Устройство Sham tDCS
  Sham tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)

Первичные конечные точки

• Mini-Linguistic State Examination [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Naming of trained words [Срок оценки: 6 monhts]
• ACE-III [Срок оценки: 6 months]
• Interview for Deterioration in Daily Living Activities in Dementia (IDDD) [Срок оценки: 6 months]
• Communicative Effectiveness Index (CETI) [Срок оценки: 6 months]
• CDR(R) plus NACC FTLD-SB [Срок оценки: 6 months]
• Neuropsychiatric Inventory (NPI) [Срок оценки: 6 months]
• FDG-PET imaging [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Diagnosis of PPA according to the current consensus criteria proposed by Gorno-Tempini et al., 2011), based on the presence of progressive language impairment as the most prominent and primary cause of functional decline and the exclusion of other medical, psychiatric, or non-neurodegenerative causes,a s well as early prominent memory, visuoperceptual or behavioral disturbances;
• Diagnosis of one of the three variants of PPA (non-fluent, semantic, or logopenic) according to the consensus criteria (Gorno-Tempini et al., 2011), based on the language profile and supported by neuroimaging (FDG-PET or MRI).
• Clinical Dementia Rating scale equal or less than 1;
• The language impairment is the main neurological deficit for the patient.

Критерии исключения

• Patient diagnosed with a condition other than PPA that could cause language impairment;
• History of epilepsy or presence of focal epileptiform pathology on EEG recording; ·Contraindications related to the treatments or procedures to be used (TMS and tDCS), such as ferromagnetic material, pregnancy, or breastfeeding;
• Terminal illness or active malignancy;
• Alcohol or substance abuse within the past year;
• Major psychiatric disorders (schizophrenia, schizoaffective disorders, bipolar disorder, obsessive-compulsive disorder, or personality disorders);
• Absolute inability to communicate (mutism), or poor command of the language that, in the investigator's judgment, would prevent participation in the study;
• Severity of PPA that prevents participation in interventions or assessments at the time of inclusion;
• Participation in another clinical trial within the previous 4 months;
• Chronic use of medications that could affect study outcomes;
• Antiepileptic drugs: allowed if on stable doses for at least 3 months before inclusion. If needed during the study due to seizure occurrence, they may be added;
• Diazepam and derivatives: permitted only if on stable doses for at least 3 months before inclusion. Dose adjustments during the study are allowed;
• Donepezil, Galantamine, Rivastigmine, and Memantine: allowed if on stable doses for at least 3 months before inclusion;
• SSRIs (Selective Serotonin Reuptake Inhibitors): permitted only if on stable doses for at least 3 months prior to inclusion. If necessary during the study, they may be added;
• Medications that may lower the seizure threshold (e.g., tricyclic antidepressants, antipsychotics): allowed if on stable doses for at least 3 months before inclusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Clinico San Carlos — Madrid

Публикации

• Fernandez-Romero L, Diez-Cirarda M, Delgado-Alonso C, Cabrera-Martin MN, Gonzalez-Rosa JJ, Sanz-Nieto C, Perez-Macias N, Balugo P, Gomez-Ruiz N, Matias-Guiu J, Portoles-Perez A, Matias-Guiu JA. Long-term effect of transcranial magnetic stimulation and transcranial electrical stimulation in primary progressive aphasia: study protocol for a randomised, double-blind clinical trial (RECONNECT-PLUS). B PMID 42161537

Идентификаторы

NCT: NCT07158216 · Hospital Clinico San Carlos

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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