Figura 1. Diagrama de flujo del estudio. EMTr: estimulación magnética transcraneal repetitiva.
Tabla. Comparación de las principales características por grupo de tratamiento |
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Placebo |
Activo |
p a |
||
Edad media (años) |
65,6 ± 13,4 |
61,9 ± 13,9 |
0,232 |
|
Sexo (masculino) |
22 (55%) |
20 (50%) |
0,654 |
|
Estrato socioeconómico |
Bajo |
17 (42,5%) |
23 (58,9%) |
0,298 |
Medio |
17 (42,5%) |
13 (33,3%) |
||
Alto |
6 (15 %) |
3 (7,7%) |
||
Estado civil |
Soltero |
5 (12,8%) |
3 (7,9%) |
0,831 |
Casado |
21 (53,9%) |
24 (63,2%) |
||
Unión libre |
5 (12,8%) |
6 (15,8%) |
||
Divorciado |
3 (7,7%) |
2 (5,3%) |
||
Viudo |
5 (12,8%) |
3 (7,9%) |
||
Antecedentes patológicos |
Diabetes mellitus tipo 1 |
9 (23,6%) |
9 (25,7%) |
0,841 |
Hipertensión arterial |
25 (67,6%) |
25 (67,6%) |
1,000 |
|
Ictus |
23 (62,2%) |
20 (51,3%) |
0,339 |
|
Fibrilación auricular |
9 (23,1%) |
7 (19,4%) |
0,701 |
|
Dislipidemia |
14 (36,8%) |
8 (22,2%) |
0,169 |
|
Escala de Rankin modificada |
Baja (0-2) |
15 (37,5%) |
11 (28,9%) |
0,060 |
Media (3-4) |
23 (57,5%) |
18 (47,4%) |
||
Alta (5-6) |
2 (5%) |
9 (23,7%) |
||
Tiempo postictus (meses) b |
12,8 (5,7-37,3) |
9,21 (5,3-30,8) |
0,418 |
|
Índice de Barthel |
Dependencia total (0-20) |
4 (10,3%) |
7 (18,4%) |
0,316 |
Gran dependencia (21-60) |
9 (23,1%) |
8 (21,1%) |
||
Dependencia moderada (61-90) |
15 (38,5%) |
17 (44,7%) |
||
Dependencia escasa (91-99) |
8 (20,5%) |
2 (5,3%) |
||
Independencia (100) |
3 (7,7%) |
4 (10,5%) |
||
Variables neuropsicológicas |
Ansiedad b |
28 (26-33) |
29,5 (25-34) |
0,820 |
Depresión b |
34,5 (30-37,5) |
37 (31-42) |
0,274 |
|
Escala análoga de calidad de vida |
71,8 ± 20,2 |
67,8 ± 20,9 |
0,407 |
|
Neuropsi b |
25,5 (10-47,8) |
17,8 (8-35) |
0,154 |
|
Gravedad de la afasia según test de Boston |
Leve (4-5) |
1 (2,44%) |
1 (2,44%) |
0,301 |
Moderada (2-3) |
13 (31,7%) |
7 (17,1%) |
||
Grave (0-1) |
27 (65,8%) |
33 (80,5%) |
||
Habla narrativa b |
42,9 (11,6-50) |
42,5 (33,8-50) |
0,992 |
|
Comprensión auditivab |
10,2 (7,3-12,9) |
8,2 (4,2-10,4) |
0,024 |
|
Denominaciónb |
1 (0-5,4) |
0 (0-2) |
0,014 |
|
Lecturab |
0,4 (0-5,6) |
0 (0-1,8) |
0,074 |
|
Escriturab |
0,0 (0-0) |
0 (0-0) |
0,699 |
|
Praxisb |
10 (5,3-13,3) |
7,3 (3-10) |
0,026 |
|
a Test t o U de Mann-Whitney para las variables continuas y prueba de chi al cuadrado para las variables categóricas; b Mediana (Q1-Q3). |
Figura 2. Eficacia de la estimulación magnética transcraneal: grupo placebo frente a grupo activo el día 30 para los diferentes dominios del test de Boston. a U de Mann-Whitney.
Efficacy and safety of transcranial magnetic stimulation in patients with non-fluent aphasia, following an ischaemic stroke. A controlled, randomised and double-blind clinical trial Introduction. Non-fluent aphasia is a frequent complication in post-ischemic stroke patients, with repetitive transcranial magnetic stimulation (rTMS) being one of the possible treatment alternatives. Aim. To assess the efficacy and safety of rTMS in patients with non-fluent after-ischemic stroke aphasia. Patients and methods. Double blind, randomized controlled clinical trial in post-stroke patients who were assigned to receive 10 sessions (one daily) of active treatment or placebo of rTMS, without the addition of language therapy. The baseline characteristics were compared initially and the efficacy between the active group versus the placebo group at day 30 was evaluated through a Mann-Whitney U test. Results. 82 patients were included: active group (n = 41) and placebo group (n = 41). At baseline, statistically significant differences were found between the groups in favor of the placebo in the domains of the Boston test of auditory compression (p = 0.024), denomination (p = 0.014) and praxis (p = 0.026), and also occurred on the 30th day in the naming domains (p = 0.037) and reading (p = 0.001). There were 39 adverse reactions: 23 (26.83%) in the active group vs 16 (21.96%) in the placebo group (p = 0.290); the majority corresponded to episodes of mild headache. Conclusion. rTMS is a safe therapy, however, given the conditions of this study, we could not demonstrate the efficacy of rTMS versus placebo in patients with non-fluent aphasia with involvement of Broca’s area after an ischemic stroke. Key words. Non-fluent aphasia. Repetitive transcranial magnetic stimulation. rTMS. Stroke. |