106 patients were screened and after exclusion 50 patients were enrolled, of which 38 were male and 12 females. 25 patients randomised to active (rTMS) group and rest 25 to sham group (Figure 2).
Patients in active group were comparatively younger, also active group had more male and less female patients. Other baseline parameters such as risk factors, duration of illness, type of stroke, size of stroke, spasticity across each joint and strength of handgrip were similar in both groups (Table 1).
Table 1. Baseline characteristics of patients in both groups
VARIABLE
|
rTMS group (n=25)
|
Sham group (n=25)
|
P value
|
Age (years)
|
52.84±11.53
|
58±11.47
|
.14
|
Sex
Male
Female
|
22
3
|
16
9
|
.06
|
Risk factors
DM
HTN
Smoker
|
13
7
2
|
11
8
3
|
.96
.96
.96
|
Duration of stroke (months)
|
21.36±29.22
|
20.36±17.50
|
.88
|
Type of stroke
Ischaemic
Haemorrhagic
|
13
12
|
14
11
|
1.00
|
Location of stroke
Cortical
Subcortical
|
8
17
|
4
21
|
.32
|
Size of stroke
Small
Medium
Large
|
7
10
8
|
10
8
7
|
.66
|
Degree of spasticity (mMAS)
Shoulder
Elbow
Wrist
Fingers
|
2.83±1.16
3.33±.96
3.08±1.06
2.54±1.25
|
2.30±.92
2.91±.94
2.70±.87
2.09±.90
|
.093
.13
.17
.16
|
Hang grip (kg)
|
3.03±3.30
|
3.38±3.29
|
.71
|
HTN: hypertension, DM: diabetes mellitus, mMAS: modified-modified Ashworth score
Outcomes: Mean amplitude of MEP on stimulation of normal side showed significant reduction [1.98±1.70 mV before therapy and 1.53±1.16 mV after therapy, p value of .001 (95% CI .135 - .630)]. There was significant increase in latency after therapy [22.92±2.25 ms vs 24.26±2.62 ms with p value 0.001 (95% CI -2.0 - -.96)]. No significant change in amplitude (1.05±.69 mV vs 1.17±1.01 mV) or increase in latency (23.66±2.45 ms vs 24.05±2.58 ms) after therapy in was found in sham group (Table 2, Figure 3)
Table 2: Changes in MEP parameters in both hemispheres among both groups and spasticity across each joint, before and after therapy in each group
|
rTMS group (n=24)
|
Sham group (n=23)
|
Before (mean±SD)
|
After (mean±SD)
|
P value
|
Before (mean±SD)
|
After (mean±SD)
|
P value
|
Normal hemisphere
|
Amp (mV)
|
1.98±1.70
|
1.53±1.16
|
.001
|
1.05±.69
|
1.17±1.01
|
.45
|
L1 (ms)
|
22.92±2.25
|
24.26±2.62
|
.001
|
23.66±2.45
|
24.05±2.58
|
.31
|
Abnormal hemisphere
|
Amp (mV)
|
.94±1.67
|
.77±.70
|
.74
|
.61±.76
|
.84±.78
|
.23
|
L1 (ms)
|
26.69±3.87
|
24.99±3.42
|
.005
|
27.05±4.65
|
26.45±5.05
|
.55
|
Spasticity (mMAS)
|
Shoulder
|
2.83±1.16
|
2.13±1.03
|
.001
|
2.30±.92
|
2.22±.99
|
.16
|
Elbow
|
3.33±.96
|
2.58±1.06
|
.001
|
2.91±.94
|
2.83±.93
|
.16
|
Wrist
|
3.08±1.06
|
2.0±.88
|
.001
|
2.70±.87
|
2.65±.98
|
.57
|
Fingers
|
2.54±1.25
|
1.71±1.16
|
.001
|
2.09±.90
|
2.04±.92
|
.57
|
Amp-Amplitude, L1- latency, mMAS: modified-modified Ashworth score
On abnormal side there was significant decrease in latency after rTMS therapy (26.69±3.87 ms vs 24.99±3.42 ms, p=0.005). Decrement in latency in sham group was not significant (27.05±4.65 ms vs 26.45±.05 ms, p=0.55). However, no significant increase in amplitude was found after rTMS therapy (.94±1.67 mV vs.77±.70 mV) (Figure 3,4).
We also calculated the percentage change in MEP latency and amplitude and found similar results. There was increase in latency (-5.85±4.87) and decrease in amplitude (18.22±29.32) in non-affected hemisphere. In affected hemisphere there was decrease in latency (6.09±5.15) and increase in amplitude (-101±178.47) (Figure 5).
There was significant reduction in spasticity across each joint after rTMS therapy [(shoulder 2.83±1.16 vs 2.13±1.03, p=0.001), (elbow 3.33±.96 vs 2.58±1.06, p=0.001), (wrist 3.08±1.06 vs 2.0±.88, p=0.001), (fingers 2.54±1.25 vs 1.71±1.16, p=0.001)]. No difference in spasticity was seen in sham group (Table 2, Figure 6).
In active group we could not find any relationship between improvement in spasticity and MEP values. None of the patients experienced any adverse events like seizure, headache, hearing loss or tingling sensation in face.