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Cited by 80Neurological disorders and treatmentsObsessive-Compulsive Spectrum DisordersTranscranial Magnetic Stimulation Studies

Long versus short pulse width subcallosal cingulate stimulation for treatment-resistant depression: a randomised, double-blind, crossover trial

Ramasubbu, Rajamannar, Clark, Darren L, Golding, Sandra, Dobson, Keith S, Mackie, Aaron, Haffenden, Angela, Kiss, Zelma HT·2020·The Lancet Psychiatry
DOI 10.1016/s2215-0366(19)30415-8
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Abstract

Background Stimulation adjustment is required to optimise outcomes of deep brain stimulation (DBS) for treatment-resistant depression, but controlled data for ideal stimulation parameters are poor or insufficient. We aimed to establish the efficacy and safety of short pulse width (SPW) and long pulse width (LPW) subcallosal cingulate DBS in depression.Methods We did a double-blind, randomised, crossover trial in an academic hospital in Calgary, AB, Canada. Patients had DSM IV-defined major depressive disorder and bipolar depression (20-70 years old, both sexes) and did not respond to treatment for more than 1 year, with a score of 20 or more on the 17-item Hamilton Depression Rating Scale (HDRS) at recruitment. Patients underwent bilateral DBS implantation into the subcallosal cingulate white matter using diffusion tensor imaging tractography. Patients were randomly assigned 1:1 without stratification using a computerised list generator to receive either SPW (90 μs) or LPW (210-450 μs) stimulation for 6 months. Patients and the clinician assessing outcomes were masked to the stimulation group. Keeping frequency constant (130 Hz), either pulse width or voltage was increased monthly, based on response using the HDRS. Patients who did not respond to treatment (<50% reduction in HDRS from baseline) at 6 months crossed over to the opposite stimulation for another 6 months. All patients received individualised cognitive behavioural therapy (CBT) for 12 weeks. The primary outcome was change in HDRS at 6 months and 12 months using intention-to-treat analysis. This study is registered with ClinicalTrials.gov, NCT01983904.Findings Between Dec 5, 2013, and Sept 30, 2016, of 225 patients screened for eligibility, 23 patients were selected for DBS surgery. After one patient withdrew, 22 (mean age 46·4 years, SEM 3·1; 10 [45%] female, 12 [55%] male) were randomly assigned, ten (45%) to LPW stimulation and 12 (55%) to SPW stimulation. Patients were followed up at 6 months and 12 months. There was a significant reduction in HDRS scores (p<0·0001) with no difference between SPW and LPW groups (p=0·54) in the randomisation phase at 6 months. Crossover groups did not show a significant decrease in HDRS within groups (p=0·15) and between groups (p=0·21) from 6-12 months. Adverse events were equal between groups. Worsening anxiety and depression were the most common psychological adverse events. One patient in the SPW group died by suicide.Interpretation Both LPW and SPW stimulation of subcallosal cingulate white matter tracts carried similar risks and were equally effective in reducing depressive symptoms, suggesting a role for both pulse width and amplitude titration in optimising clinical outcomes in patients with treatment-resistant depression.Funding Alberta Innovates Health Solutions.

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  • Studies of subcallosal cingulate cortex DBS for treatment-resistant depression generally use fixed frequency (130 Hz) and pulse-width (90 μs).

    “While in general, studies of SCC DBS for TRD use fixed frequency (130 Hz) and pulse-width (90 μs), three studies were specifically designed to test effects of different stimulation parameters [32][33][34].”

    From Deep brain stimulation for depression. (2022) · cites this paper as [34]

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Authors
Ramasubbu, R., Clark, D. L., Golding, S., Dobson, K. S., Mackie, A., Haffenden, A., & Kiss, Z. H.
Affiliations
University of Calgary (CA)
Corresponding author
Ramasubbu, Rajamannar
ORCID
Venue
The Lancet Psychiatry
Publisher
Elsevier BV
Published
2020-01
Volume
7
Issue
1
Pages
29-40
ISSN
2215-0366 (ISSN-L)
DOI
10.1016/s2215-0366(19)30415-8
OpenAlex
W2996346053
Cited by
80
References
36
Citations by year
2026: 7 · 2025: 9 · 2024: 15 · 2023: 14 · 2022: 11 · 2021: 13 · 2020: 10 · 2019: 1
FWCI
5.90
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Neurology › Neurological disorders and treatments
  • Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
  • Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
Keywords
treatment-resistant depression, deep brain stimulation, subcallosal cingulate, pulse duration, stimulation parameters, major depressive disorder, bipolar depression, cognitive behavioral therapy, diffusion tensor tractography, Hamilton Depression Rating Scale, crossover design, depression remission, adverse events, quality of life
MeSH terms
Bipolar Disorder, Canada, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Cognitive Behavioral Therapy, Treatment Outcome, Prefrontal Cortex, Cross-Over Studies, Deep Brain Stimulation, Diffusion Tensor Imaging, Depressive Disorder, Treatment-Resistant

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