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Updated: Nov 12, 2025
Author Spotlight: Therapeutic Benefit of Closed-Loop Deep Brain Stimulation in Depression Treatment
Published on: July 7, 2023
Recruitment Challenges for Studies of Deep Brain Stimulation for Treatment-Resistant Depression
Rajamannar Ramasubbu1,2,3,4, Sandra Golding1,2, Kimberly Williams1
1Department of Psychiatry, University of Calgary, Calgary, AB, Canada.
Introduction:
Deep brain stimulation (DBS) is currently an investigational treatment for treatment-resistant depression (TRD). There is a need for more DBS trials to strengthen existing evidence of its efficacy for both regulatory and clinical reasons. Recruitment for DBS trials remains challenging due to unproven efficacy in sham-controlled DBS trials, invasive nature of the intervention and stringent eligibility criteria in patient selection. Here, we examined the referral patterns and reasons for exclusion of subjects in our DBS trial.
Methods:
Data were collected from all patients who expressed interest in participating in a DBS study involving subcallosal cingulate region from 2014 to 2016. Referral sources were categorized as either self-referral or professional referral. Evaluation for eligibility was performed in three stages; initial contact, brief telephone assessment, and in-person psychiatric evaluation. The reasons for exclusion were documented. Descriptive and inferential statistics were used for analysis.
Results:
Of the 225 patients who contacted us initially, 22 (9.2%) underwent DBS surgery. Self-referral was higher than the referral from professionals (72% versus 28%, P<0.0001). However, the acceptance rate for surgery was higher among the professional referrals than from self-referrals (40% versus 15%, P=0.03). The common reasons for exclusion were self-withdrawal (38.4%), residing out of province or country (26.1%) and psychiatric/medical comorbidity (21.7%).
Conclusion:
These findings provide insight into DBS candidacy for future TRD trials. It suggests a need for comprehensive recruitment strategies including active engagement of patients and professionals throughout trials, and effective referral communication with education to optimize recruitment for future DBS trials.
Insights
Recruiting for deep brain stimulation (DBS) trials for treatment-resistant depression (TRD) is challenging. Professional referrals have higher acceptance rates than self-referrals, indicating a need for improved recruitment strategies.
Area of Science:
- Neuroscience
- Psychiatry
- Surgical Innovation
Background:
- Deep brain stimulation (DBS) is an investigational treatment for treatment-resistant depression (TRD).
- Further clinical trials are needed to establish DBS efficacy for TRD.
- Patient recruitment for DBS trials faces challenges due to its invasive nature and stringent eligibility criteria.
Purpose of the Study:
- To analyze referral patterns and exclusion reasons in a deep brain stimulation (DBS) trial for treatment-resistant depression (TRD).
- To identify factors influencing patient recruitment and selection for DBS studies.
Main Methods:
- Collected data from patients interested in a subcallosal cingulate DBS study (2014-2016).
- Categorized referrals as self or professional, and evaluated eligibility through multiple stages.
- Documented exclusion reasons and analyzed data using descriptive and inferential statistics.
Main Results:
- Only 9.2% of 225 initial contacts underwent DBS surgery.
- Self-referrals (72%) were more common than professional referrals (28%), but professional referrals had higher acceptance rates (40% vs. 15%).
- Top exclusion reasons included self-withdrawal (38.4%), geographical distance (26.1%), and comorbidities (21.7%).
Conclusions:
- Findings offer insights into deep brain stimulation (DBS) candidacy for treatment-resistant depression (TRD) trials.
- Recommends comprehensive recruitment strategies, including patient and professional engagement.
- Highlights the importance of effective referral communication and education to optimize future DBS trial recruitment.
