Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep brain stimulation (DBS) in patients with treatment resistant depression (TRD).
The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to improvements in TRD patients, and specific neuroimaging biomarkers will correlate with response to DBS; the functional recovery will be enhanced with concurrent cognitive behavioural therapy (CBT).
The aim is to collect data on prediction, optimization and augmentation of DBS for TRD and develop tools for DBS surgery. It is a biological pilot study designed to provide informative data for future work.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Pulse Width | Experimental | deep brain stimulation with short & long pulse width |
|
| Short Pulse Width | Experimental | deep brain stimulation with short & long pulse width |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation with short & long pulse width | Device | surgical implantation for bilateral electrodes and stimulation using short and long pulse width |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale | change in HDRS from baseline before surgery: rates of remission (defined as an HDRS score <8 at 6 and 12 months) and response (defined as >50% reduction in HDRS) | 6 and 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on Illness Density Index, Montgomery-Asberg Depression Rating Scale and Hamilton Anxiety Scale, Positive and Negative Affect Scale, Clinical Global Impression of Change, GAF< SAs, NAS, Q-LES-Q-SF & neuropsychological tests | change in MADRS score from baseline before surgery to 6 and 12 months post operatively | 6 and 12 months post operatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zelma H Kiss, MD PhDFRCSC | University of Calgary, Department of Clinical Neurosciences | Principal Investigator |
| Rajamannar Ramasubbu, MD MRCP FRCP | University of Calgary, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary & Alberta Health Services, Foothills Medical Centre | Calgary | Alberta | T2N 4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38185882 | Derived | Ramasubbu R, Brown EC, Mouches P, Moore JA, Clark DL, Molnar CP, Kiss ZHT, Forkert ND. Multimodal imaging measures in the prediction of clinical response to deep brain stimulation for refractory depression: A machine learning approach. World J Biol Psychiatry. 2024 Mar;25(3):175-187. doi: 10.1080/15622975.2023.2300795. Epub 2024 Jan 17. | |
| 31860455 |
Not provided
Not provided
undecided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Post Cognitive Behavioural Therapy Scores | Changes in primary and secondary measures from pre-CBT scores will be used | 15 months post operatively |
| Ramasubbu R, Clark DL, Golding S, Dobson KS, Mackie A, Haffenden A, Kiss ZH. Long versus short pulse width subcallosal cingulate stimulation for treatment-resistant depression: a randomised, double-blind, crossover trial. Lancet Psychiatry. 2020 Jan;7(1):29-40. doi: 10.1016/S2215-0366(19)30415-8. |