Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-10-04
Brief Title:
Cognitive Remediation of Working Memory Post Head Trauma
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma a SCED Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Meta-SCED
Brief Summary:
Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises transcranial direct current stimulation tDCS and therapeutic education
Detailed Description:
This study is a multiple baseline Single Case Experimental Design SCED across 3 patients and 2 behaviors working memory performance application of compensatory strategies
The remediation program will include 4 intervention phases and include patients with moderate or severe head trauma and expressing a cognitive complaint of working memory during the neuropsychological screening examination
These patients will benefit from a neuropsychological assessment at inclusion then cognitive remediation treatment consisting of 4 phases The duration of the baseline will be randomized At the end of phases C and D a new neuropsychological examination will be carried out
Patients will have to come twice a week for 12 weeks All sessions will be individual
Phase A Therapeutic education Weeks 1 to 4 This first phase will include therapeutic education sessions lasting 90 minutes The themes covered will concern Head trauma in the chronic phase Cognitive and behavioral disorders secondary to traumatic brain injury TBI will not be addressed The duration of this phase will be randomized
Phase B tDCS therapeutic education Weeks 5 to 8 During this intervention phase at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of therapeutic education
Concerning tDCS stimulation an electrical current of 2mA will be delivered using the electrodes for 20 min The content of the therapeutic education sessions will be developed in the same way as for phase A
Phase C tDCS cognitive remediation Weeks 9 to 12 During this intervention phase at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of specific cognitive remediation of working memory
The cognitive remediation program will combine working memory retraining using computerized and paper-and-pencil supports as well as more ecological exercises that respond precisely to the difficulties encountered by the patient in daily life
The remediation program will include 4 intervention phases and include patients with moderate or severe head trauma and expressing a cognitive complaint of working memory during the neuropsychological screening examination
These patients will benefit from a neuropsychological assessment at inclusion then cognitive remediation treatment consisting of 4 phases The duration of the baseline will be randomized At the end of phases C and D a new neuropsychological examination will be carried out
Patients will have to come twice a week for 12 weeks All sessions will be individual
Phase A Therapeutic education Weeks 1 to 4 This first phase will include therapeutic education sessions lasting 90 minutes The themes covered will concern Head trauma in the chronic phase Cognitive and behavioral disorders secondary to traumatic brain injury TBI will not be addressed The duration of this phase will be randomized
Phase B tDCS therapeutic education Weeks 5 to 8 During this intervention phase at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of therapeutic education
Concerning tDCS stimulation an electrical current of 2mA will be delivered using the electrodes for 20 min The content of the therapeutic education sessions will be developed in the same way as for phase A
Phase C tDCS cognitive remediation Weeks 9 to 12 During this intervention phase at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of specific cognitive remediation of working memory
The cognitive remediation program will combine working memory retraining using computerized and paper-and-pencil supports as well as more ecological exercises that respond precisely to the difficulties encountered by the patient in daily life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None