Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02999282
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2016-12-02
Brief Title:
Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
Rehabilitative Trial for the Recovery of Neurophysiological Parameters in Progranulin Mutation Carriers Through the Use of Transcranial Direct Current Stimulation tDCS
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReRescuePGR
Brief Summary:
In this randomized double-blind sham-controlled study the investigators will evaluate the effects of frontal and prefrontal anodal transcranial direct current stimulation tDCS on neurophysiological parameters of cortical connectivity assessed by transcranial magnetic stimulation TMS in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia
Detailed Description:
In this randomized double-blind sham-controlled study the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation tDCS on neurophysiological parameters of cortical connectivity assessed by transcranial magnetic stimulation TMS in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia
All patients will undergo genetic screening for progranulin mutations a baseline neuropsychological and neurophysiological evaluation including assessment of short interval intracortical inhibition intracortical facilitation short interval intracortical facilitation and long interval intracortical inhibition Subjects will then be randomized in two groups one receiving a 10 day 5 daysweek for 2 weeks treatment with anodal frontal and prefrontal anodal tDCS and the other receiving sham stimulation with identical parameters After the intervention patients will be reassessed with a neuropsychological and neurophysiological evaluation at 2 weeks 1 month only neurophysiological evaluation 3 months and 6 month after treatment
All patients will undergo genetic screening for progranulin mutations a baseline neuropsychological and neurophysiological evaluation including assessment of short interval intracortical inhibition intracortical facilitation short interval intracortical facilitation and long interval intracortical inhibition Subjects will then be randomized in two groups one receiving a 10 day 5 daysweek for 2 weeks treatment with anodal frontal and prefrontal anodal tDCS and the other receiving sham stimulation with identical parameters After the intervention patients will be reassessed with a neuropsychological and neurophysiological evaluation at 2 weeks 1 month only neurophysiological evaluation 3 months and 6 month after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None