Long-term Effect of TMS in Primary Progressive Aphasia

Alzheimer Disease Clinical Trial

— RECONNECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05842473
• Other study ID #: 21/731-EC_P
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Device:
• 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.

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

Device:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Metabolism	Changes in FDG-PET imaging (Standard Uptake Value ratio)	0 and 6 months
Secondary	Spontaneous language	Changes in Words per minute	0, 3 and 6 months
Secondary	Language assessment (Mini-Linguistic State Examination)	Changes in Mini-Linguistic State Examination test	0, 3 and 6 months
Secondary	Language assessment (trained words)	Changes in trained words accuracy (number of words)	0, 3 and 6 months
Secondary	Language assessment (untrained words)	Changes in untrained words accuracy (number of words)	0, 3 and 6 months
Secondary	Daily-living activities	Changes in Interview for Deterioration in Daily living in Dementia Scale	0, 3 and 6 months
Secondary	Neuropsychiatric symptoms	Changes in Neuropsychiatric Inventory scale	0, 3 and 6 months