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Background Chemotherapy-induced peripheral neuropathy (CIPN) can affect functional performance and quality of life considerably. Since balance training has proven to enhance physical function, it might be a promising strategy to manage CIPN-induced functional impairments. Methods Fifty cancer survivors with persisting CIPN after finishing their treatment were randomly allocated to an intervention (IG) or active control group (CG). The IG did endurance plus balance training, the CG only endurance training (twice weekly over 12 weeks). Pre- and post-assessments included functional performance, cardiorespiratory fitness, vibration sense, and self-reported CIPN symptoms (EORTC QLQ-CIPN20). Results Intention-to-treat analyses ( n  = 41) did not reveal a significant group difference (CG minus IG) for sway path in semi-tandem stance after intervention (primary endpoint), adjusted for baseline. However, our per-protocol analysis of 37 patients with training compliance ≥70% revealed: the IG reduced their sway path during semi-tandem stance (− 76 mm, 95% CI -141 – -17; CG: -6 mm, 95% CI -52 – 50), improved the duration standing on one leg on instable surface (11 s, 95% CI 8–17; CG: 0 s, 95%CI 0–5) and reported decreased motor symptoms (−8points, 95% CI -18 – 0; CG: -2points 95% CI -6 – 2). Both groups reported reduced overall- (IG: -10points, 95% CI -17 – -4; CG: -6points, 95% CI -11 – -1) and sensory symptoms (IG: -7points, 95% CI -15 – 0; CG: -7points, 95% CI -15 – 0), while only the CG exhibited objectively better vibration sense (knuckle: 0.8points, 95% CI 0.3–1.3; IG: 0.0points, 95% CI -1.1 – 0.9; patella: 1.0points, 95% CI 0.4–1.6: IG: -0.8points, 95% CI -0.2 – 0.0). Furthermore, maximum power output during cardiopulmonary exercise test increased in both groups (IG and CG: 0.1 W/kg, 95% CI 0.0–0.2), but only the CG improved their jump height (2 cm, 95% CI 0.5–3.5; IG: 1 cm, 95% CI -0.4 – 3.2). Conclusion We suppose that endurance training induced a reduction in sensory symptoms in both groups, while balance training additionally improved patients’ functional status. This additional functional effect might reflect the IG’s superiority in the CIPN20 motor score. Both exercises provide a clear and relevant benefit for patients with CIPN. Trial registration German Clinical Trials Register (DRKS) number: DRKS00005419 , prospectively registered on November 19, 2013.

The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference ( p  = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety. Trial Registration : clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.

Introduction Breast cancer is the most common cancer disease of women in industrialized countries. Neurotoxic chemotherapy drugs are known to harm peripheral nerves and cause a chemotherapy-induced peripheral neuropathy (CIPN). CIPN is one of the most common adverse events associated with Paclitaxel chemotherapy and may remain present long after the termination of chemotherapy. Thus, it reduces the patients’ quality of life (QoL) both during chemotherapy and onwards, and can impose a danger on breast cancer survivors due to an increased risk of falling and fall-related injuries. Methods The aim of this randomized-controlled trial (RCT) ( n  = 36) (IG: intervention group, n  = 17) (CG: control group, n  = 19) was to determine whether sensorimotor exercises have a positive effect on physical and psychological parameters in breast cancer patients undergoing neurotoxic chemotherapy (Paclitaxel). Results As a result, we were able to show significant improvements in postural stability in monopedal stance [left leg 16.17 ± 3.67 vs. 21.55 ± 5.33 ( p  < 0.001) and right leg 15.14 ± 2.30 vs. 20.85 ± 5.05 ( p  < 0.001)] and in bipedal stance [T1 vs. T0, − 0.49 (IG) vs. + 1.14 (CG) p  = 0.039]. Discussion These results in posturography correlate with the clinical presentation with intervention group patients scoring significantly better on the Fullerton Advanced Balance Scale [37.71 ± 2.73 vs. 34.47 ± 3.98 ( p  = 0.004)]. Moderate strength training successfully prevented a strength loss in the IG that was remarkable in the CG (− 1.60 vs. 0.60, p  = 0.029). Concerning the psychological parameters assessed via EORTC- and MFI-questionnaires, no significant improvements were found. Conclusion Future studies should focus on the correlation of clinical and posturometry findings and subjective QOL such as the long-term-development of CIPN.

Background Functional neurological disorder (FND) is a common neurological presentation with symptoms such as seizures, walking difficulties, limb weakness and cognitive difficulties. Treatments for FND include physiotherapy and psychological therapy. Eye movement desensitisation and reprocessing therapy (EMDR) is a therapy designed to reduce disturbance associated with distressing or traumatic memories. Case report evidence suggests possible benefit for people with FND. This randomised feasibility study aimed to assess whether a large-scale trial evaluating EMDR for FND would be feasible and acceptable. Methods Fifty participants with FND were randomised to either FND-focused EMDR plus standard neuropsychiatric care (NPC) or NPC alone. Feasibility criteria were recruitment rate, intervention adherence, and outcome measure completion. Assessment of safety was also examined, as well as therapy satisfaction. Participants completed questionnaires at baseline, 3 months, 6 months and 9 months. FND symptoms were assessed using Ecological Momentary Assessment at each time point. Results Recruitment rate was 58%, intervention adherence was 88%, and outcome measure completion was 68% for Ecological Momentary Assessment and 76% for questionnaires at 9-month follow-up. Participants experienced functional motor symptoms (80%), functional seizures (64%), and cognitive symptoms (32%). Participants receiving EMDR + NPC reported greater satisfaction and greater FND improvement compared to NPC. Questionnaire data suggested greater reductions in PTSD, depression, anxiety, dissociation, disability and healthcare-use for EMDR + NPC. Discussion The study demonstrated that an FND-specific protocol for EMDR was feasible and acceptable. Potential positive effects on FND symptoms, mental health, disability, and healthcare utilisation were found. A full-scale trial is warranted to establish efficacy. Trial Registration NCT05455450 ( www.clinicaltrials.gov ).

Background Social cognitive impairments often occur in patients with various neurological disorders that involve brain damage, such as traumatic brain injury, stroke, brain tumours, and multiple sclerosis. Patients with social cognitive impairments experience difficulties in perceiving and understanding social information and show social inadequate behaviour. Recently, the first multi-faceted treatment, T-ScEmo (Treatment for Social Cognition and Emotion Regulation) has been developed and evaluated for patients with TBI. T-ScEmo showed to be effective in improving social cognitive functioning, participation, relationships, and quality of life. Up to now, no evidence-based treatment has been available for social cognitive impairments in neurological patients other than traumatic brain injury. Therefore, the main aims of the current study are to investigate the efficacy of T-ScEmo in various neurological patient groups such as stroke (including subarachnoid haemorrhage), brain tumours, and multiple sclerosis and to study factors that might influence this, potential, efficacy. Methods In this multi-centre, assessor-blind randomized controlled trial, 84 patients with mixed aetiology will be randomly divided over a treatment condition and a waiting list condition. Patients in treatment condition will follow twenty T-ScEmo sessions, of which five are online. Neuropsychological assessment and questionnaires directly after treatment (T1) and follow-up (T2, three to five months after treatment) will be compared to baseline assessment (T0). Ten TBI patients who receive T-ScEmo as regular rehabilitation care will be included as an extra control group. The main outcome measure will be the comparison of proxy rated behaviour between T0 and T2 on the Dysexecutive Questionnaire Social scales proxy version. Moreover, a compact barrier analysis is performed to facilitate the implementation of the treatment and to provide input for a process evaluation in the current study protocol. Discussion When T-ScEmo is proven effective based on the current study, this will be the first effectual evidence-based multi-faceted treatment for patients with social cognitive impairments caused by various neurological disorders. Implementation of this treatment is expected to contribute to better participation and better quality of life for patients and their significant others. Trial registration This study is prospectively registered in the database PaNaMa under number 202000479. Furthermore the study is registered in the database of clinicaltrials.gov (Study Details | Improving Social Cognition and Social Behaviour in Various Brain Disorders | ClinicalTrials.gov) under identifier NCT06330298.

Objective. Chemotherapy-induced peripheral neuropathy (CIPN) syndrome causes significant pain as an adverse effect of treatment, with few nonpharmacological interventions tested. A somatic yoga and meditation (SYM) intervention on functional outcomes and quality of life (QOL) was investigated. Design and methods. Individuals diagnosed with CIPN were enrolled in an open-label, single-arm, mixed-methods feasibility trial. Participants and Setting. In an outpatient rehabilitation center, ten participants with median age 64.4 years (47-81) attended 61% of the sessions with no adverse events. Intervention. SYM twice a week for 8 weeks for 1.5 hours, with home program and journaling. Main outcome measures. Primary functional outcomes included Sit and Reach (SR), Functional Reach (FR), and Timed Up and Go (TUG). Self-reported Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy—Neurotoxicity (FACT-GOG-NTX) were secondary CIPN outcomes. Biomarkers included salivary cortisol (stress) and bioesthesiometer (vibration). Results: Quantitative findings. Significant improvements were found in flexibility (SR; P = .006); balance (FR; P = .001) and fall risk (TUG; P = .004). PNQ improved significantly (P = .003) with other measures improving non-significantly. Qualitative findings. Five themes emerged: (1) vacillation of CIPN pain perception over time; (2) transferability of skills to daily activities; (3) improvement in physical function; (4) perceived relaxation as an effect of SYM; and (5) group engagement provided a social context for not feeling isolated with CIPN. Conclusion. Preliminary data suggest SYM may improve QOL, flexibility, and balance in cancer survivors with CIPN, with a fully powered randomized controlled trial indicated. Trial registration: NCT03786055

Background Yoga is a meditative movement therapy focused on mind‐body awareness. The impact of yoga on health‐related quality of life (HRQOL) outcomes in patients with chemotherapy‐induced peripheral neuropathy (CIPN) is unclear. Methods We conducted a pilot randomized wait‐list controlled trial of 8 weeks of yoga (n = 21) versus wait‐list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models. Results At week 8, HADS anxiety scores decreased −1.61 (−2.75, −0.46) in the yoga arm and −0.32 (−1.38, 0.75) points in the wait‐list control arm (p = 0.099). At week 12, HADS anxiety scores decreased −1.42 (−2.57, −0.28) in yoga compared to an increase of 0.46 (−0.60, 1.53) in wait‐list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait‐list control. Baseline TES was significantly higher in yoga than in wait‐list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction. Conclusions Yoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings. Clinical Trial Registration Number: ClinicalTrials.gov Identifier: NCT03292328. The impact of yoga on health‐related quality of life (HRQOL) outcomes in patients with chemotherapy‐induced peripheral neuropathy (CIPN) is unclear. We conducted a pilot randomized wait‐list controlled trial of 8 weeks of yoga versus wait‐list control for CIPN in breast and gynecological cancer survivors with persistent moderate to severe CIPN. Our results showed a trend for yoga to decrease anxiety, but not Hospital Anxiety and Depression Scale depression scores, Brief Fatigue Inventory, or the Insomnia Severity Index, at weeks 8 and 12 compared to wait‐list control; future studies are needed to confirm these findings.

Objective The objective of this study was to evaluate users’ driving performances with a Power Wheelchair (PWC) driving simulator in comparison to the same driving task in real conditions with a standard power wheelchair. Methods Three driving circuits of progressive difficulty levels (C1, C2, C3) that were elaborated to assess the driving performances with PWC in indoor situations, were used in this study. These circuits have been modeled in a 3D Virtual Environment to replicate the three driving task scenarios in Virtual Reality (VR). Users were asked to complete the three circuits with respect to two testing conditions during three successive sessions, i.e. in VR and on a real circuit (R). During each session, users completed the two conditions. Driving performances were evaluated using the number of collisions and time to complete the circuit. In addition, driving ability by Wheelchair Skill Test (WST) and mental load were assessed in both conditions. Cybersickness, user satisfaction and sense of presence were measured in VR. The conditions R and VR were randomized. Results Thirty-one participants with neurological disorders and expert wheelchair drivers were included in the study. The driving performances between VR and R conditions were statistically different for the C3 circuit but were not statistically different for the two easiest circuits C1 and C2. The results of the WST was not statistically different in C1, C2 and C3. The mental load was higher in VR than in R condition. The general sense of presence was reported as acceptable (mean value of 4.6 out of 6) for all the participants, and the cybersickness was reported as acceptable (SSQ mean value of 4.25 on the three circuits in VR condition). Conclusion Driving performances were statistically different in the most complicated circuit C3 with an increased number of collisions in VR, but were not statistically different for the two easiest circuits C1 and C2 in R and VR conditions. In addition, there were no significant adverse effects such as cybersickness. The results show the value of the simulator for driving training applications. Still, the mental load was higher in VR than in R condition, thus mitigating the potential for use with people with cognitive disorders. Further studies should be conducted to assess the quality of skill transfer for novice drivers from the simulator to the real world. Trial registration Ethical approval n ∘ 2019-A001306-51 from Comité de Protection des Personnes Sud Mediterranée IV. Trial registered the 19/11/2019 on ClinicalTrials.gov in ID: NCT04171973.