Clinical trial NCT06077695: Cognitive Remediation of Working Memory Post Head Trauma
Official title: Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head Trauma
Keywords: working memory
cognitive remediation
transcranial direct current stimulation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design : SCEDs evaluate the effectiveness of an intervention by recruiting a small number of individuals (typically between 1 and 3). They are different from single case studies (or case reports). SCEDs are based on repeated measurements, sequential introduction of the intervention and specific visual and statistical methods of analyzing the results. The strength of SCED lies in the large number of repeated measurements and not in the number of subjects included.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Moderate or severe head trauma, defined by an initial Glasgow score ≤ 12/15, duration of post-traumatic amnesia superior to 24 hours and/or the presence of abnormalities on brain imaging,
* Moderate or severe head trauma occurring within a period greater than or equal to 3 months,
* Working memory complaints assessed by the Working Memory Questionnaire,
* Patients with a working memory disorder in at least one of the following tests: Digit Memory subtest WAIS-IV (standard deviation ≤ -2) , PASAT (percentile ≤ 10), Brown-Peterson (standard deviation ≤ -2).

Exclusion Criteria:

* Presence of aphasia, apraxia or severe neglect demonstrated by standardized neuropsychological tests during the inclusion visit: language - oral naming of BECS-GRECO images, ideational praxis and ideomotor , neglect - bell test,
* Insufficient visual or auditory abilities and oral and written expression to carry out neuropsychological tests,
* Severe depression assessed by the Beck Depression Inventory (BDI)
* Chronic alcoholic poisoning, drug addiction,
* Progressive general illness,
* Progressive psychiatric or neurological condition leading to cognitive impairment,
* Hospitalization for a neurological pathology since the acute phase of the qualifying event,
* Patient requiring surgery during study participation.
* Pregnant or breastfeeding women

Primary outcomes:
measure: Working memory performance
timeFrame: 8 weeks after baseline
Secondary outcomes:
measure: Goal attainment
timeFrame: 8 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Adeline Julien
role: PRINCIPAL_INVESTIGATOR
References: