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New treatment option for Primary Progressive Aphasia(PPA)
Official title Long Term Effect of Brain Stimulation in PPA
ClinicalTrials.gov ID: NCT07158216
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of PPA according to the current consensus criteria proposed by Gorno-Tempini et al., 2011), based on the presence of progressive language...
- Diagnosis of one of the three variants of PPA (non-fluent, semantic, or logopenic) according to the consensus criteria (Gorno-Tempini et al., 2011)...
- Clinical Dementia Rating scale equal or less than 1;
- The language impairment is the main neurological deficit for the patient.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- Clinical Dementia Rating scale equal or less than 1;
- The language impairment is the main neurological deficit for the patient.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.