Ignite Creation Date:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-23 @ 6:06 PM
Study NCT ID:
NCT06077695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-10-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Remediation of Working Memory Post Head Trauma
Sponsor:
University Hospital, Toulouse
Organization:
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:
False
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?: