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Long Term Effect of Brain Stimulation in PPA

ConditionPrimary Progressive Aphasia(PPA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital San Carlos, Madrid

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TMS

    Device

    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)

  • tDCS

    Device

    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)

  • Sham TMS

    Device

    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)

  • Sham tDCS

    Device

    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)

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: active TMS + active tDCSExperimental treatment 2 interventions
Group B: active TMS + sham tDCSExperimental treatment 2 interventions
Group C: sham TMS + active tDCSExperimental treatment 2 interventions
Group D: sham TMS + sham tDCSSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mini-Linguistic State Examination

Time frame
6 months

Secondary outcomes

1

Naming of trained words

It will be evaluated using a list of 261 words from eight semantic categories (animals, food, objects, places, furniture, clothing, transportation, and body parts)

Time frame
6 monhts
2

ACE-III

General cognition

Time frame
6 months
3

Interview for Deterioration in Daily Living Activities in Dementia (IDDD)

Functional activities

Time frame
6 months
4

Communicative Effectiveness Index (CETI)

Functional communication questionnaire

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital San Carlos, Madrid

Lead sponsor

Source ClinicalTrials.gov
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