One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression

Renana Eitan; Denys Fontaine; Michel Benoît; Caroline Giordana; Nelly Darmon; Zvi Israel; Eduard Linesky; David Arkadir; Shiri Ben-Naim; Moshe Iserlles; Hagai Bergman; Natasha Hulse; Mohamed Abdelghani; Peter McGuffin; Anne Farmer; Peichel DeLea; Keyoumars Ashkan; Bernard Lerer

doi:10.1016/j.jpsychires.2017.09.026

One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression

Renana Eitan, Denys Fontaine, Michel Benoît, Caroline Giordana, Nelly Darmon, Zvi Israel, Eduard Linesky, David Arkadir, Shiri Ben-Naim, Moshe Iserlles, Hagai Bergman, Natasha Hulse, Mohamed Abdelghani, Peter McGuffin, Anne Farmer, Peichel DeLea, Keyoumars Ashkan, Bernard Lerer

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Abstract

Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (−15.4 ± 21.1 and −14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (−23.4 ± 19.9 (n = 6 periods) and −13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (−31.3 ± 19.3 (n = 4 patients) and −7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters.

Original language	English
Journal	Journal of psychiatric research
Early online date	3 Oct 2017
DOIs	https://doi.org/10.1016/j.jpsychires.2017.09.026
Publication status	E-pub ahead of print - 3 Oct 2017

Keywords

Deep brain stimulation
Subcallosal cingulate area
Treatment resistant major depressive disorder
High frequency stimulation
Low frequency stimulation

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10.1016/j.jpsychires.2017.09.026

One year double blind study_EITAN_Accepted29September2017_GREEN AAM (CC BY-NC-ND)Accepted author manuscript, 1.42 MBLicence: CC BY-NC-ND

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Eitan, R., Fontaine, D., Benoît, M., Giordana, C., Darmon, N., Israel, Z., Linesky, E., Arkadir, D., Ben-Naim, S., Iserlles, M., Bergman, H., Hulse, N., Abdelghani, M., McGuffin, P., Farmer, A., DeLea, P., Ashkan, K., & Lerer, B. (2017). One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression. Journal of psychiatric research. Advance online publication. https://doi.org/10.1016/j.jpsychires.2017.09.026

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title = "One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression",

abstract = " Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (−15.4 ± 21.1 and −14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (−23.4 ± 19.9 (n = 6 periods) and −13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (−31.3 ± 19.3 (n = 4 patients) and −7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters.",

keywords = "Deep brain stimulation, Subcallosal cingulate area, Treatment resistant major depressive disorder, High frequency stimulation, Low frequency stimulation",

author = "Renana Eitan and Denys Fontaine and Michel Beno{\^i}t and Caroline Giordana and Nelly Darmon and Zvi Israel and Eduard Linesky and David Arkadir and Shiri Ben-Naim and Moshe Iserlles and Hagai Bergman and Natasha Hulse and Mohamed Abdelghani and Peter McGuffin and Anne Farmer and Peichel DeLea and Keyoumars Ashkan and Bernard Lerer",

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Eitan, R, Fontaine, D, Benoît, M, Giordana, C, Darmon, N, Israel, Z, Linesky, E, Arkadir, D, Ben-Naim, S, Iserlles, M, Bergman, H, Hulse, N, Abdelghani, M , McGuffin, P , Farmer, A, DeLea, P, Ashkan, K & Lerer, B 2017, 'One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression', Journal of psychiatric research. https://doi.org/10.1016/j.jpsychires.2017.09.026

TY - JOUR

T1 - One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression

AU - Eitan, Renana

AU - Fontaine, Denys

AU - Benoît, Michel

AU - Giordana, Caroline

AU - Darmon, Nelly

AU - Israel, Zvi

AU - Linesky, Eduard

AU - Arkadir, David

AU - Ben-Naim, Shiri

AU - Iserlles, Moshe

AU - Bergman, Hagai

AU - Hulse, Natasha

AU - Abdelghani, Mohamed

AU - McGuffin, Peter

AU - Farmer, Anne

AU - DeLea, Peichel

AU - Ashkan, Keyoumars

AU - Lerer, Bernard

PY - 2017/10/3

Y1 - 2017/10/3

N2 - Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (−15.4 ± 21.1 and −14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (−23.4 ± 19.9 (n = 6 periods) and −13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (−31.3 ± 19.3 (n = 4 patients) and −7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters.

AB - Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (−15.4 ± 21.1 and −14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (−23.4 ± 19.9 (n = 6 periods) and −13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (−31.3 ± 19.3 (n = 4 patients) and −7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters.

KW - Deep brain stimulation

KW - Subcallosal cingulate area

KW - Treatment resistant major depressive disorder

KW - High frequency stimulation

KW - Low frequency stimulation

U2 - 10.1016/j.jpsychires.2017.09.026

DO - 10.1016/j.jpsychires.2017.09.026

M3 - Article

SN - 0022-3956

JO - Journal of psychiatric research

JF - Journal of psychiatric research

ER -

One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression

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Keywords

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