Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 10:31 PM
Study NCT ID:
NCT01636661
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Status:
COMPLETED
Status Verified Date:
2015-10
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:
tDCS
Brief Summary:
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
1. tDCS will not produce a major adverse event, including seizure activity.
2. No change in paretic or nonparetic hand function or cognitive status will occur.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
1. tDCS will not produce a major adverse event, including seizure activity.
2. No change in paretic or nonparetic hand function or cognitive status will occur.
Detailed Description:
Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.
Study Oversight
Has Oversight DMC:
False
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?: