Jean-Michel Mazaux

Fluoxetine in early poststroke depression : A double-blind placebo-controlled study

BACKGROUND AND PURPOSEnEarly poststroke depression (PSD) is a frequent and specific entity that impairs the rehabilitation and functional recovery of hemiplegic patients. This trial was designed to study the efficacy and tolerance of fluoxetine (FLX) in the treatment of early PSD.nnnMETHODSnThis was a multicenter, double-blind, placebo-controlled study. Recent hemiplegic patients (<3 months) suffering from major depressive disorder (determined by International Classification of Diseases, 10th Revision, and Montgomery-Asberg Depression Rating Scale [MADRS] >19) were randomized to receive either 20 mg/d fluoxetine (FLX) or placebo for 6 weeks. Patients were evaluated by use of the Motricity Index, Mini-Mental State Examination, Functional Independence Measure, and MADRS. Statistical analysis was performed by using an intent-to-treat approach comparing the 2 groups at day 0 (baseline) and days 15, 30, and 45 (end point).nnnRESULTSnOf 121 patients screened, 31 were included in the study, 16 in the FLX group and 15 in the placebo group. There were no significant differences in baseline characteristics among the 2 groups. The FLX-treated patients compared with placebo-treated patients demonstrated significant improvement in mean MADRS scores at end point (11.8+/-6. 7 [mean+/-SD] versus 18.7+/-10.0, respectively; P=0.05). FLX-treated patients compared with placebo-treated patients also demonstrated greater response rate (62.5% versus 33.3%, respectively) and greater mean decrease of MADRS (16.6 versus 8.4, respectively; P=0.02). There were no differences in motor, cognitive, or functional improvement and no significant side effects after FLX treatment, except for a patient with a moderate and transient increase of transaminases.nnnCONCLUSIONSnFLX is an efficacious and well-tolerated treatment for early PSD. Further research is needed to evaluate the efficacy and safety of long-term treatment in this population.

Long-term neuropsychological outcome and loss of social autonomy after traumatic brain injury

OBJECTIVEnTo assess which social activities were still impaired 5 years after a traumatic brain injury (TBI) in adults, and which neuropsychological impairments were associated with this loss of social autonomy.nnnDESIGNnCross-sectional study of 79 patients selected from the follow-up cohort of an epidemiologic survey of 2,116 TBI patients.nnnSETTINGnThe present study was of ambulatory patients seen at hospital or at their homes. The inception cohort was from the trauma center of a university hospital and from a general hospital that is representative of level II trauma centers in Aquitaine, France.nnnPATIENTSnSeventy-nine patients selected from a representative sample of 407 patients who were included in the 5-year follow-up study of the initial cohort (convenience sample).nnnMAIN OUTCOME MEASURESnGlasgow Outcome Scale (GOS) and loss of social autonomy as assessed by the European Brain Injury Societys European Head Injury Evaluation Chart; assessment of neurobehavioral impairments by means of the Neurobehavioral Rating Scale-Revised.nnnRESULTSnUp to 16 patients suffered disability for at least one social skill because of cognitive/behavioral reasons. Seven needed full-time supervision. Performing administrative tasks and financial management, writing letters and calculating, driving, planning the week, and using public transport were the most impaired social abilities. Loss of social autonomy was mainly observed in severely injured patients. Univariate analysis showed that mental fatigability, motor slowing, memory difficulties, and disorders of executive function were associated with low scores on the GOS, unemployment, and difficulties in shopping, using public transport, and performing financial management and administrative tasks.nnnCONCLUSIONnPersistent impairments of executive functions and speed of psychomotor processing are major factors associated with loss of social autonomy and inability to return to work long after TBI in adults. Improving these impairments in concrete social situations represents a major challenge for cognitive rehabilitation.

Functional MRI follow-up study of language processes in healthy subjects and during recovery in a case of aphasia.

Background and Purpose— The goal of this study was to develop a functional MRI (fMRI) paradigm robust and reproducible enough in healthy subjects to be adapted for a follow-up study aiming at evaluating the anatomical substratum of recovery in poststroke aphasia. Methods— Ten right-handed subjects were studied longitudinally using fMRI (7 of them being scanned twice) and compared with a patient with conduction aphasia during the first year of stroke recovery. Results— Controls exhibited reproducible activation patterns between subjects and between sessions during language tasks. In contrast, the patient exhibited dynamic changes in brain activation pattern, particularly in the phonological task, during the 2 fMRI sessions. At 1 month after stroke, language homotopic right areas were recruited, whereas large perilesional left involvement occurred later (12 months). Conclusions— We first demonstrate intersubject robustness and intrasubject reproducibility of our paradigm in 10 healthy subjects and thus its validity in a patient follow-up study over a stroke recovery time course. Indeed, results suggest a spatiotemporal poststroke brain reorganization involving both hemispheres during the recovery course, with an early implication of a new contralateral functional neural network and a later implication of an ipsilateral one.

Botulinum a toxin and detrusor sphincter dyssynergia: a double-blind lidocaine-controlled study in 13 patients with spinal cord disease.

OBJECTIVEnTo compare the efficacy and tolerance of botulinum A toxin (BTx) versus lidocaine (L), applied in the external urethral sphincter with a single transperineal injection in order to treat detrusor sphincter dyssynergia (DSD) in spinal cord injured patients.nnnMETHODSnThirteen patients (1F, 12 M) suffering from chronic urinary retention due to DSD were randomised to receive one transperineal injection of 100 IU BTx Botox degrees in 4 ml of 9% saline (botulinum group, (BG)) or 4 ml of 0.5% L (lidocaine group, (LG)). The main criteria of efficacy was post-voiding residual urine volume (PRUV), assessed three times daily on day one (D1), D7 and D30 after each injection. Other criteria were micturition diary, satisfaction score (SS), maximal urethral pressure (MUP), maximum detrusor pressure (DP) and type of DSD, recorded on D0 and D30.nnnRESULTSnIn the BG, there was a significant decrease in PRUV (D7: -141.4 ml (p<0.03); D30: -159.4 ml (p<0.01)), in MUP (D30: -32 cm H(2)O, p<0.04) whereas no significant improvement was shown in the LG. SS was higher in BG than LG (p<0.02). DSD improved in BG whereas it remained unchanged in LG. All LG patients also received one injection of BTx on D30. They still presented improvement in PRUV and MUP 1 month later (D30). Tolerance appeared satisfactory in both groups.nnnCONCLUSIONSnThe preliminary results of this initial randomised double-blind study clearly demonstrated the superiority of BTx compared to L in improving clinical symptoms and urethral hypertonia associated with DSD in spinal cord injured patients.

Psycho-social factors and coping strategies as predictors of chronic evolution and quality of life in patients with low back pain: A prospective study

Low back pain (LBP) is a major problem of public health. Chronic pain is the most difficult to treat and the most expensive. The way patients cope with their pain may influence its outcome.

Capsaicin and neurogenic detrusor hyperreflexia: A double‐blind placebo‐controlled study in 20 patients with spinal cord lesions

The aim of this study was to investigate the efficacy and tolerance of capsaicin, a neurotoxin for C‐fiber afferents, applied intravesically in the treatment of detrusor hyperreflexia. Eleven male and nine female patients who had spinal cord lesions caused by multiple sclerosis (12) or trauma (eight) resulting in detrusor hyperreflexia with urge incontinence and pollakiuria were randomized to receive one intravesical instillation of either 30 mg capsaicin in 100 ml 30% ethanol or 100 ml 30% ethanol alone. The patients were evaluated clinically (voiding diary) and urodynamically (maximum cystometric capacity, maximum detrusor pressure, first and normal desire to void) before and 30 days after the instillation. On day 30, the 10 patients who received capsaicin had significant decreases in 24‐h voiding frequency from 9.3 ± 6.1 to 6.7 ± 3.8 (P = 0.016) and leakages from 3.9 ± 1.6 to 0.6 ± 0.8 (P = 0.0008); their maximum cystometric capacity increased from 169 ± 68 to 299 ± 96 ml (P = 0.01) and maximum detrusor pressure decreased from 77 ± 24 to 53 ± 27 cm H2O. There were no significant changes in the control group. In seven subjects in each group, instillation triggered immediate side effects (suprapubic pain, sensory urgency, flushes, hematuria, autonomic hyperreflexia) that resolved within 2 weeks. Intravesical capsaicin significantly improves clinical and urodynamic parameters of detrusor hyperreflexia in spinal cord–injured patients. Side effects are frequent, tolerable, and identical to those induced by 30% ethanol alone. Neurourol. Urodynam. 17:513–524, 1998.

Exploring theory of mind after severe traumatic brain injury.

Previous studies have reported a dissociation between social behavioral impairments after severe traumatic brain injury (TBI) and relatively preserved performances in traditional tasks that investigate cognitive abilities. Theory of mind (ToM) refers to the ability to make inferences about others mental states and use them to understand and predict others behavior. We tested a group of 15 patients with severe TBI and 15 matched controls on a series of four verbal and non-verbal ToM tasks: the faux pas test, the first-order and second-order false belief task, the character intention task and the Reading the Mind in the Eyes Test. Participants with severe TBI were also compared to controls on non-ToM inference tasks of indirect speech act from the Montreal Evaluation of Communication (M.E.C.) Protocol and empathy (Davis Interpersonal Reactivity Index - I.R.I.) and tests for executive functions. Subjects with TBI performed worse than control subjects on all ToM tasks, except the first-order false belief task. The findings converge with previous evidence for ToM deficit in TBI and dissociation between ToM and executive functions. We show that ToM deficit is probably distinct from other aspects of social cognition like empathy and pragmatic communication skills.

The neurobehavioural rating scale-revised: sensitivity and validity in closed head injury assessment

OBJECTIVES To investigate the factor structure and psychometric properties of the neurobehavioural rating scale-revised (NRS-R) and to determine its usefulness in clinical trials. METHODS A consecutive series of patients sustaining severe closed head injury were evacuated to one of 11 large regional North American trauma centres and entered into a randomised, phase III, multicentre clinical trial investigating the therapeutic use of moderate hypothermia. Acute care personnel were blinded to outcome and outcome personnel were blinded to treatment condition. The Glasgow outcome scale (GOS) was the primary outcome measure. Secondary outcome measures included the disability rating scale (DRS) and the NRS-R. RESULTS Exploratory factor analysis of NRS-R data collected at 6 months after injury (n=210) resulted in a five factor model including: (1) executive/cognition, (2) positive symptoms, (3) negative symptoms, (4) mood/affect, and (5) oral/motor. These factors showed acceptable internal consistency (0.62 to 0.88), low to moderate interfactor correlations (0.19 to 0.61), and discriminated well between GOS defined groups. Factor validity was demonstrated by significant correlations with specific neuropsychological domains. Significant change was measured from 3 to 6 months after injury for the total score (sum of all 29 item ratings) and all factor scores except mood/affect and positive symptoms. The total score and all factor scores correlated significantly with concurrent GOS and DRS scores. CONCLUSIONS The NRS-R is well suited as a secondary outcome measure for clinical trials as its completion rate exceeds that of neuropsychological assessment and it provides important neurobehavioural information complementary to that provided by global outcome and neuropsychological measures.

Assessment of neuropsychologic impairments after head injury: Interrater reliability and factorial and criterion validity of the Neurobehavioral Rating Scale–Revised

OBJECTIVEnTo study interrater reliability and factorial and criterion validity of the Neurobehavioral Rating Scale-Revised (NRS-R).nnnDESIGNnValidity study on persons with traumatic brain injury (TBI) and test-retest reliability study on a randomly selected subset of patients. Factor analyses, kappa statistics, intraclass correlation coefficients, and Cronbachs alphas were used.nnnSETTINGnInpatients from 15 French hospitals, mainly rehabilitation units. Other recruitment sites included a neurology hospital unit and a psychiatry hospital specifically devoted to TBI rehabilitation.nnnPATIENTSnTwo hundred eighty-six TBI patients ages 16 to 70 years (convenience sample).nnnRESULTSnFor the reliability study, the average of percentages of agreement among the items was 74.3% and the average of kappa statistics was .40. Factor analyses disclosed a maximum likelihood extraction of 5 correlated factors (F), explaining 42.2% of total variance: (F1) deficits in intentional behavior and in memory, (F2) lowering of emotional state, (F3) emotional and behavioral hyperactivation, (F4) lowering of arousal state and of attention, and (F5) language and speech problems. Results support the criterion validity of the factors. Reliability of the factor scores and internal consistencies of factors were very good.nnnCONCLUSIONSnResults describe some important properties of the NRS-R and, through an understanding of its underlying structure and relationships with the patients clinical characteristics, contribute to the conceptual framework of neuropsychologic impairments after TBI.

Rehabilitation of divided attention after severe traumatic brain injury: A randomised trial

Patients with severe traumatic brain injury (TBI) frequently suffer from a difficulty in dealing with two tasks simultaneously. However, there has been little research on the rehabilitation of divided attention. The objective of the present study was to assess the effectiveness of a rehabilitation programme for divided attention after severe TBI. Twelve patients at a subacute/chronic stage after a severe TBI were included. A randomised AB vs. BA cross-over design was used. Training lasted six weeks, with four one-hour sessions per week. It was compared to a non-specific (control) cognitive training. During experimental treatment, patients were trained to perform two concurrent tasks simultaneously. Each one of the two tasks was first trained as a single task, then both tasks were given simultaneously. A progressive hierarchical order of difficulty was used, by progressively increasing task difficulty following each patients individual improvement. Patients were randomised in two groups: one starting with dual-task training, the other with control training. Outcome measures included target dual-task measures, executive and working memory tasks, non-target tasks, and the Rating Scale of Attentional Behaviour addressing attentional problems in everyday life. Assessment was not blind to treatment condition. A significant training-related effect was found on dual-task measures and on the divided attention item of the Rating Scale of Attentional Behaviour. There was only little effect on executive measures, and no significant effect on non-target measures. These results suggest that training had specific effects on divided attention and helped patients to deal more rapidly and more accurately with dual-task situations.