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Long-term Effect of TMS in Primary Progressive Aphasia

NCT ID: NCT05842473

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Progressive Aphasia Frontotemporal Dementia Alzheimer Disease

Keywords

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brain stimulation transcranial magnetic stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TMS active + language therapy

TMS (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.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (active)

Intervention Type 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

Intervention Type BEHAVIORAL

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

TMS sham + language therapy

TMS (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.

Group Type SHAM_COMPARATOR

Language therapy

Intervention Type BEHAVIORAL

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

Transcranial Magnetic Stimulation (sham)

Intervention Type 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.

Interventions

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Transcranial Magnetic Stimulation (active)

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

Intervention Type DEVICE

Language therapy

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

Intervention Type BEHAVIORAL

Transcranial Magnetic Stimulation (sham)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jordi A Matias-Guiu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordi A Matias-Guiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Locations

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Hospital Clínico San Carlos.

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40788648 (View on PubMed)

Other Identifiers

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21/731-EC_P

Identifier Type: -

Identifier Source: org_study_id