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

Primary Purpose

Head Trauma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic education
tDCS
cognitive remediation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Trauma focused on measuring working memory, cognitive remediation, transcranial direct current stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    4 weeks phase A arm

    5 weeks phase A arm

    6 weeks phase A arm

    Arm 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

    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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Goal attainment
    The difference in Goal Attainment Scale (GAS) scores between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation). Each goal is personalized with the patient. The scale has 5 types of score each representing a goal attainment status (expectation) : 2 being the further away form expectation 1 a little less than aimed 0 meaning that the goal set is attained 1 a little more than what was aimed 2 exceeds a lot expectations

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 4, 2023
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077695
    Brief Title
    Cognitive Remediation of Working Memory Post Head Trauma
    Acronym
    Meta-SCED
    Official Title
    Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head Trauma
    Keywords
    working memory, cognitive remediation, transcranial direct current stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    Investigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    9 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    4 weeks phase A arm
    Arm Type
    Experimental
    Arm 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
    Arm Title
    5 weeks phase A arm
    Arm Type
    Experimental
    Arm 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
    Arm Title
    6 weeks phase A arm
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    therapeutic education
    Intervention Description
    The themes covered concern head trauma in the chronic phase.
    Intervention Type
    Other
    Intervention Name(s)
    tDCS
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    cognitive remediation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Working memory performance
    Description
    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.
    Time Frame
    8 weeks after baseline
    Secondary Outcome Measure Information:
    Title
    Goal attainment
    Description
    The difference in Goal Attainment Scale (GAS) scores between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation). Each goal is personalized with the patient. The scale has 5 types of score each representing a goal attainment status (expectation) : 2 being the further away form expectation 1 a little less than aimed 0 meaning that the goal set is attained 1 a little more than what was aimed 2 exceeds a lot expectations
    Time Frame
    8 weeks after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adeline Julien
    Phone
    05 61 77 97 21
    Email
    julien.ade@chu-toulouse.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clemence Le Bervet
    Email
    lebervet.c@chu-toulouse.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adeline Julien
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cognitive Remediation of Working Memory Post Head Trauma

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