scholarly journals What are the barriers to participation in a neuromodulation pilot trial for aphasia after stroke?

CoDAS ◽  
2021 ◽  
Vol 33 (4) ◽  
Author(s):  
Mariana Lopes Andreoli ◽  
Juli Thomaz de Souza ◽  
Priscila Watson Ribeiro ◽  
Rafael Dalle Molle da Costa ◽  
Taís Regina da Silva ◽  
...  

ABSTRACT Purpose Aphasia is a common and debilitating manifestation of stroke. Transcranial electrical stimulation uses low-intensity electric currents to induce changes in neuronal activity. Recent evidence suggests that noninvasive techniques can be a valuable rehabilitation tool for patients with aphasia. However, it is difficult to recruit patients with aphasia for trials, and the reasons for this are not well understood. This study aimed to elucidate the main difficulties involved in patient’s recruitment and inclusion in a randomized clinical study of neuromodulation in aphasia. Methods We evaluated the reasons for the exclusion of patients in a pilot, randomized, double-blinded clinical trial in which patients diagnosed with motor aphasia after stroke were recruited from March to November 2018. A descriptive statistical analysis was performed. Results Only 12.9% (4) of patients with ischemic stroke were included in the clinical trial. A total of 87.1% (27) of the 31 recruited patients were excluded for various reasons including: sensory aphasia (32.2%), dysarthria (25.8%), spontaneous clinical recovery (16.1%), previous stroke (6.4%), and death or mutism (3.2%). Conclusion The presence of other types of aphasia, dysarthria, spontaneous recovery, deaths, and mutism were barriers to recruiting patients evidenced in this neuromodulation study.

2013 ◽  
Vol 18 (6) ◽  
pp. e101-e106 ◽  
Author(s):  
Ceferino Maestú ◽  
Manuel Blanco ◽  
Angel Nevado ◽  
Julia Romero ◽  
Patricia Rodríguez-Rubio ◽  
...  

BACKGROUND: Exposure to electromagnetic fields has been reported to have analgesic and antinociceptive effects in several organisms.OBJECTIVE: To test the effect of very low-intensity transcranial magnetic stimulation on symptoms associated with fibromyalgia syndrome.METHODS: A double-blinded, placebo-controlled clinical trial was performed in the Sagrado Corazón Hospital, Seville, Spain. Female fibromyalgia patients (22 to 50 years of age) were randomly assigned to either a stimulation group or a sham group. The stimulation group (n=28) was stimulated using 8 Hz pulsed magnetic fields of very low intensity, while the sham group (n=26) underwent the same protocol without stimulation. Pressure pain thresholds before and after stimulation were determined using an algometer during the eight consecutive weekly sessions of the trial. In addition, blood serotonin levels were measured and patients completed questionnaires to monitor symptom evolution.RESULTS: A repeated-measures ANOVA indicated statistically significant improvement in the stimulation group compared with the control group with respect to somatosensory pain thresholds, ability to perform daily activities, perceived chronic pain and sleep quality. While improvement in pain thresholds was apparent after the first stimulation session, improvement in the other three measures occurred after the sixth week. No significant between-group differences were observed in scores of depression, fatigue, severity of headaches or serotonin levels. No adverse side effects were reported in any of the patients.CONCLUSIONS: Very low-intensity magnetic stimulation may represent a safe and effective treatment for chronic pain and other symptoms associated with fibromyalgia.


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  

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