Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01169181
Status:
UNKNOWN
Last Update Posted:
2016-12-08
First Post:
2010-07-22
Brief Title:
AMES Brain Stimulation
Sponsor:
AMES Technology
Organization:
AMES Technology
Study Overview
Official Title:
AMES Brain Stimulation Treatment for Profound Plegia in Stroke
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
AMES
Brief Summary:
The procedure involves 1 assisted hand movement by a mechanical device 2 mechanical vibration applied to the surface of the forearm and 3 stimulation of the brain with either transcranial magnetic stimulation TMS or transcortical direct current stimulation DCS These 3 components of the procedure are carried out simultaneously Each subject will be evaluated pre- and post-treatment with several clinical tests of functional movement The hypotheses of this project are that the AMESrTMS and AMEStDCS procedures are safe and will enable most of the stroke patients to recover finger extension
Detailed Description:
This protocol is designed to investigate the safety and efficacy of a procedure for treating chronic 1 year post stroke patients who still cannot move the hand affected by the stroke The treatment involves 1 assisted hand movement by a mechanical device 2 mechanical vibration applied to the surface of the forearm and 3 stimulation of the brain with either transcranial magnetic stimulation TMS or transcortical direct current stimulation DCS Subjects receiving TMS during treatment are expected to respond more fully ie increased volitional EMG in the treated hand compared to those receiving DCS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R43NS067694-01A1 | NIH | None | httpsreporternihgovquickSearch1R43NS067694-01A1 |