Table 88Efficacy and other comparative harms outcomes of rTMS versus sham in post-stroke depression subpopulations: all Tiers, MDD

Author, year
Study Design
Primary Endpoint(s)
Quality
Intervention and Sample Size
Study Details
Population CharacteristicsResponse
Remission
Change in Depressive Symptoms
Adverse Events
Quality of Life
Attrition
Jorge et al., 2008129
Experiment 1
RCT, primary endpoint at 3 weeks, mITT
Failure required in current episode
Tier 2
Fair
rTMS (n = 15)
High frequency, 10 sessions
Sham (n = 15)
Concurrent medications
All antidepressants discontinued
Strategy
Switch
Definitions
Remission: HAM-D17 < 8 and did not meet criteria for major or minor depression
Subgroup
Patients with stroke/cerebral vascular disease
Diagnosis,%
MDD: 100
Baseline Depression:
HAM-D17
rTMS: 19.5 (5.8)
Sham: 19.9 (5.4)
HAM-D17
Response, n (%)
rTMS: 5 (33.3)
Sham: 1 (6.7)
P = 0.08
Remission, n (%)
rTMS: 2 (13.3)
Sham: 1 (6.7)
P = 0.5
Change,%
rTMS: -33.1
Sham: -13.6
P = 0.04
Adverse Events
Headache,%
rTMS: 5 (33)
Sham: 4 (27)
P = NR
No differences in frequency of headaches; all headaches were mild and responded to low dose analgesics
Local Pain, n (%)
rTMS: 1 (7)
Sham: 1 (7)
P = NR
Local discomfort, n (%)
rTMS: 4 (27)
Sham: 5 (33)
No difference in frequency of local discomfort
P = NR
Anxiety, n (%)
rTMS: 2 (13)
Sham: 0 (0)
P = NR
Seizures, n
rTMS: 0
Sham: 0
P = NR
Jorge et al., 2008129 Experiment 2
RCT, primary endpoint at 3 weeks, mITT
Failure required in current episode
Tier 2
Fair
rTMS (n = 33)
High frequency, 15 sessions
Sham (n = 29)
Concurrent medications
All antidepressants discontinued
Strategy
Switch
Definitions
Remission: HAM-D17 <8 and did not meet criteria for major or minor depression
Subgroup
Patients with stroke/cerebral vascular disease
Diagnosis,%
MDD: 100
Baseline Depression, n
(%):
HAM-D17
rTMS: 18.4 (3.4)
Sham: 17.6 (5.6)
HAM-D17
Response, n (%)
rTMS: 13 (39.4)
Sham: 2 (6.9)
P = 0.003
Remission
rTMS: 9 (27.3)
Sham: 1 (3.4)
P = 0.01
Change,%
rTMS: -42.4
Sham: -17.5
P < 0.001
Adverse Events
Headache,%
rTMS: 7 (21)
Sham: 3 (10)
No differences between groups in frequency of headaches; all headaches were mild and responded to low dose analgesics
P = NR
Local Pain, n (%)
rTMS: 1 (3)
Sham: 0 (0)
P = NR
Local discomfort, n (%)
rTMS: 3 (9)
Sham: 1 (3)
No difference in frequency of local discomfort
P = NR
Anxiety, n (%)
rTMS: 0 (0)
Sham: 0 (0)
P = NR
Seizures, n
rTMS: 0
Sham: 0
P = NR
Jorge et al., 2004130
RCT, primary outcome at 3 weeks (2 weeks of txt, 1 week followup), ITT
Failure in current episode not required
Tier 1
Fair
rTMS (n = 10)
High frequency, 10 sessions
Sham (n = 10)
Concurrent Medications
All antidepressant medications discontinued
Strategy
Switch
Subgroup
Patients with stroke/cerebral vascular disease
Diagnosis,%
MDD: 85
Minor depression: 15
Baseline Depression:
HAM-D17
rTMS: 20.1 (6.7)
Sham: 20.8 (6.0)
HAM-D17
Response, n (%)
rTMS: 3 (30)
Sham: 0 (0)
P = NS
Remission, n (%)
rTMS: 1 (10)
Sham: 0 (0)
P = NS
Change Score
rTMS: 7.3
Sham: NR (can be calculated as 2.7)
P < 0.006
Change,%
rTMS: -38
Sham: -13
Adverse Events
No significant differences in frequency of adverse events between active and sham rTMS groups
Neither group reported seizures or propagation of cortical excitability toipsilateral motor cortex

HAM-D17 = 17-item Hamilton Depression Scale; ITT = intent-to-treat analysis; MDD = major depressive disorder; mITT = modified intent-to-treat analysis; NR = not reported; NS = not significant; P = p-value; RCT = randomized controlled trial; rTMS = repetitive transcranial magnetic stimulation; txt = treatment

From: Results

Cover of Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults
Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults [Internet].
Comparative Effectiveness Reviews, No. 33.
Gaynes BN, Lux LJ, Lloyd SW, et al.

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