Cognitive Remediation of Working Memory Post Head Trauma (Meta-SCED)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Head Trauma

Treatments: Other: tDCS; Other: therapeutic education; Other: cognitive remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT06077695

RC31/22/0502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

9 participants in 3 patient groups

4 weeks phase A arm

Experimental group

Description:

Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up

Treatment:

Other: cognitive remediation

Other: therapeutic education

Other: tDCS

5 weeks phase A arm

Experimental group

Description:

Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up

Treatment:

Other: cognitive remediation

Other: therapeutic education

Other: tDCS

6 weeks phase A arm

Experimental group

Description:

Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up

Treatment:

Other: cognitive remediation

Other: therapeutic education

Other: tDCS