Status:
UNKNOWN
Evaluation of a Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Semantic Dementia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD) causes profound language dysfunction. SD damages semantic processing typically in the temporal poles (anterior t...
Detailed Description
Main objective and evaluation criteria: To evaluate the potential therapeutic efficacy of repetitive tDCS during 10 days on language/semantic impairment in SD via a double-blind sham-controlled study...
Eligibility Criteria
Inclusion
- SD-Patients:
- Patients fulfilling the international diagnosis criteria of SD (Gorno-Tempini et al., 2011): fluent speech, single word comprehension and naming deficit, +/- object recognition deficits, +/- surface agraphia or alexia. Absence of phonemic paraphasias, agrammatism and word apraxia.
- Age \> 18 years old.
- Patients have given their informed written consent.
- Affiliation to a social security regime.
- Healthy controls:
- Age \>18 years old
- Subjects have given their informed written consent.
- Subjects selected according to the matching criteria (age, sex, handedness and number of years of education).
- Affiliation to a social security regime
Exclusion
- SD-Patients:
- MADRS ≥ 20 (major depressive syndrome according to the DSM-IV-R criteria)
- MMS \< 10/30
- FAB \< 7/18
- BDAE aphasia severity rating scale \< 3/5
- Patients not having French as their mother tongue
- Other neurological pathology or general disorder or major physical deficits than can interfere with cognitive functioning
- MRI or PET contraindication, 18-FDG contraindication
- Cerebral MRI data compatible with a pathological process other than the one related to SD (Vascular, traumatic, tumoral, infectious, or metabolic brain injury). A moderate or discrete leukoaraiosis will not be considered as a non- inclusion criterion (patients with a Fazekas and Schmidt \[Fazekas et al., 1998a; fazekas et al., 1998b\],stage \>2 for hypersignals of the periventricular and deep white matter will not be included)
- The patient should not participate simultaneously in another brain therapeutic trial (possibility of bias between stimulation and evaluation of the effect on language / semantic processes)
- \- tDCS contraindications: epilepsy antecedents, presence of epilepsy risk factors (known alcoholism or metabolic troubles, antecedents of head injury or chirurgical intervention on the brain or the skull), skin lesions of the scalp, skull metal implants.
- \- Patients under curatorship or tutorship
- \- Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
- Healthy controls:
- Subjects not having French as their mother tongue
- Subjects having a neurological or psychiatric disease or major deficits than can interfere with cognitive functioning
- MRI or PET contraindication, 18-FDG contraindication
- Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03481933
Start Date
May 16 2018
End Date
September 1 2024
Last Update
January 17 2024
Active Locations (2)
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1
Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales
Paris, France, 75013
2
Hôpital de la Pitié-Salpétrière
Paris, France, 75013