Cognitive Remediation of Working Memory Post Head Trauma

NCT06077695 | Not Yet Recruiting

• 1 other identifier: RC31/22/0502
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head Trauma

Keywords

working memory; cognitive remediation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Working memory performance

  difference in performance on a working memory task (2-back) between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation) : a 2-back task is a repeated measure of working memory performance. On each trial, a stimulus will appear in the center of the screen for 500 msec. It will be followed by an inter-stimulus phase of 1500 msec. The stimulus will be a capital letter (consonants only). In this 2-back task, the subject will be asked to press the answer key as quickly as possible when the letter presented is identical to the penultimate. This task requires strong working memory and attentional resources. Error-free delay (ms), reaction times (ms) and standard deviation of reaction times (ms) will be counted.

  8 weeks after baseline

Secondary Outcomes (1)

• Goal attainment

  8 weeks after baseline

Study Arms (3)

4 weeks phase A arm

EXPERIMENTAL

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

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

5 weeks phase A arm

EXPERIMENTAL

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

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

6 weeks phase A arm

EXPERIMENTAL

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

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

Interventions

therapeutic education OTHER

The themes covered concern head trauma in the chronic phase.

4 weeks phase A arm; 5 weeks phase A arm; 6 weeks phase A arm

tDCS OTHER

The constant electric current will be delivered at an intensity of 2 mA for 20 minutes.The anode will be placed opposite the dorsolateral prefrontal area on the right. The cathode (or reference electrode) will be positioned opposite the supraorbital area on the left. This methodology is based on the general directions and results from scientific studies which aimed to improve the efficiency of neural networks engaged in attentional processes and working memory.

4 weeks phase A arm; 5 weeks phase A arm; 6 weeks phase A arm

cognitive remediation OTHER

Personalized sessions combining 2 approaches:•Retraining deficit components of working memory.exercise the strengthening of metacognition and the learning of "reorganization-facilitation" strategies. At the end of each exercise, the participant will be asked to analyze their performance and will benefit from feedback from the rehabilitator as well as a discussion on the use of the strategies. Finally, all of the proposed tasks will be made up of several levels of complexity; moving to a more complex stage will require more than 90% success in the exercise.•More ecological exercises will also be carried out in order to get as close as possible to the difficulties encountered by the patient on a daily basis. The examiner will guide the rehabilitation and propose tasks imitating his daily life.

4 weeks phase A arm; 5 weeks phase A arm; 6 weeks phase A arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Transcranial Direct Current Stimulation; Cognitive Remediation

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Study Officials

• Adeline Julien

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline Julien

CONTACT

05 61 77 97 21; julien.ade@chu-toulouse.fr

Clemence Le Bervet

CONTACT

lebervet.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Repeated measurements, control measurements and neuropsychological examinations will be carried out by an examiner blinded to the intervention phase. The rehabilitator will not carry out these assessments. A neuropsychologist from the neuropsychology unit, not involved in the design and conduct of the Meta-SCED study, will carry out these examinations.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06