Transcranial Magnetic Stimulation in Primary Progressive Aphasia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03580954 |
Recruitment Status :
Completed
First Posted : July 10, 2018
Last Update Posted : May 14, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder.
Transcranial Magnetic Stimulation (TMS) is a technique based on the principle of electromagnetic induction of an electric field in the brain. It has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, Parkinson's disease, and in the rehabilitation of post-stroke aphasia. Recent studies have shown how repetitive TMS improved language characteristics in Alzheimer's disease, and there are initial data in patients with PPA.
This research project investigates the effect of repetitive TMS in patients with PPA. Investigators will perform a personalized TMS treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Progressive Aphasia | Device: Transcranial Magnetic Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Transcranial Magnetic Stimulation in Primary Progressive Aphasia |
Actual Study Start Date : | February 1, 2018 |
Actual Primary Completion Date : | March 10, 2020 |
Actual Study Completion Date : | March 10, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Repetitive TMS (estimulation) |
Device: Transcranial Magnetic Stimulation
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions. |
Active Comparator: Repetitive TMS (inhibition) |
Device: Transcranial Magnetic Stimulation
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions. |
- Changes in spontaneous speech (main primary endpoint) [ Time Frame: 2 months (at baseline and at the end of the treatment) ]Picture and story description task
- Changes in oral naming [ Time Frame: 2 months ]Object naming test
- Changes in reading [ Time Frame: 2 months ]Story and words reading test
- Changes in repetition [ Time Frame: 2 months (at baseline and at the end of the treatment) ]Non-words and sentence repetition task
- Changes in brain metabolism [ Time Frame: 2 months (at baseline and at the end of the treatment) ]Brain metabolism measured using 18F-FDG-PET
- Changes in clinical impression of change [ Time Frame: 2 months (at baseline and at the end of the treatment) ]Patient's clinical impression of change (from 0 to 10)
- Changes in brain cortical electrical activity [ Time Frame: 2 months (at baseline and at the end of the treatment) ]Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)
- Changes in global cognition [ Time Frame: 2 months (at baseline and at the end of the study) ]Addenbrooke's Cognitive Examination III
- Changes in clinical impression of change [ Time Frame: 2 months ]Caregiver's clinical impression of change (from 0 to 10)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be clinically diagnosed of PPA according to current diagnostic criteria (Gorno-Tempini et al. 2011) with PET-FDG confirmation.
- Clinical Dementia Rating 0-1.
Exclusion Criteria:
- Contraindications for TMS or MRI
- History of epilepsy
- Pregnancy
- Other language disorder previous to the diagnosis of PPA
- Neuroimaging not suggestive of PPA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580954
Spain | |
Hospital Clínico San Carlos. | |
Madrid, Spain, 28040 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jordi A Matias-Guiu, Principal Investigator. PhD MD, Hospital San Carlos, Madrid |
ClinicalTrials.gov Identifier: | NCT03580954 |
Other Study ID Numbers: |
17/247-E |
First Posted: | July 10, 2018 Key Record Dates |
Last Update Posted: | May 14, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Aphasia Aphasia, Primary Progressive Pick Disease of the Brain Frontotemporal Dementia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Dementia Brain Diseases Central Nervous System Diseases Neurocognitive Disorders Mental Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases |