ABSTRACT
OBJECTIVES: Transcranial magnetic stimulation (TMS) has been used therapeutically for functional (conversion) motor symptoms but there is limited evidence for its efficacy and the optimal protocol. We examined the feasibility of a novel randomised controlled trial (RCT) protocol of TMS to treat functional limb weakness. DESIGN: A double-blind (patient, outcome assessor) two parallel-arm, controlled RCT. SETTING: Specialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK. PARTICIPANTS: Patients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition). Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment. INTERVENTIONS: Patients were randomised to receive either active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold). Both groups received two TMS sessions, 4 weeks apart. OUTCOME MEASURES: We assessed recruitment, randomisation and retention rates. The primary outcome was patient-rated symptom change (Clinical Global Impression-Improvement scale, CGI-I). Secondary outcomes included clinician-rated symptom change, psychosocial functioning and disability. Outcomes were assessed at baseline, both TMS visits and at 3-month follow-up. RESULTS: Twenty-two patients were recruited and 21 (96%) were successfully randomised (active=10; inactive=11). Nineteen (91%) patients were included at follow-up (active=9; inactive=10). Completion rates for most outcomes were good (80%-100%). Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%). Adverse events were not more common for the active treatment. Treatment effect sizes for patient-rated CGI-I scores were small-moderate (Cliff's delta=-0.1-0.3, CIs-0.79 to 0.28), reflecting a more positive outcome for the active treatment (67% and 44% of active arm-rated symptoms as 'much improved' at session 2 and follow-up, respectively, vs 20% inactive group). Effect sizes for secondary outcomes were variable. CONCLUSIONS: Our protocol is feasible. The findings suggest that supramotor threshold TMS of M1 is safe, acceptable and potentially beneficial as a treatment for functional limb weakness. A larger RCT is warranted. TRIAL REGISTRATION NUMBER: ISRCTN51225587.
Subject(s)
Transcranial Magnetic Stimulation , Double-Blind Method , Feasibility Studies , Humans , London , Treatment OutcomeABSTRACT
BACKGROUND: Various tests are used to detect diabetic peripheral neuropathy by assessing sense perception in the feet. Tests vary in terms of time and resources required. Simple tests are those that can be conducted quickly and easily in primary care without laboratory equipment. There are some limitations to these simple tests, an example being the variable amplitude of the 128 Hz tuning fork. A new test, VibraTip (McCallan Medical, UK), might be a valuable alternative as it emits a consistent amplitude and may offer improved diagnostic accuracy. OBJECTIVE: The aims of this study are to estimate the diagnostic accuracy of the VibraTip device for diabetic peripheral neuropathy against the reference standard of sural nerve conduction velocity measurement, and to assess whether the VibraTip offers superior diagnostic accuracy to other routine tests based on vibration or touch. METHODS: The study will prospectively recruit adults with type 2 diabetes who are due to attend a routine follow-up clinic. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be sural nerve conduction velocity measurement. RESULTS: Funding is being sought to conduct this research. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against sural nerve conduction velocity measurement, including sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. Receiver operating characteristic curves will be constructed and compared for each test. CONCLUSIONS: This study will be the first within-study comparison of 5 simple tests for screening diabetic peripheral neuropathy and will address uncertainties in the potential benefits of using VibraTip in comparison with the other tests.
ABSTRACT
The acronym CANOMAD encompasses chronic ataxic neuropathy combined with ophthalmoplegia, M protein, cold agglutinins, and anti-disialosyl antibodies.Herein we describe 2 patients presenting with progressive ataxic neuropathy who only developed ophthalmoplegia after a significant delay post-presentation, which in 1 case had features indicative of brainstem dysfunction. Both patients were found to have an IgM paraprotein and anti-disialosyl antibodies. They responded to treatment with intravenous immunoglobulin, thus illustrating the importance of diagnosing this condition.
