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Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT00837486
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Intervention Device: Reclaim™ DBS System
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation
Hide Arm/Group Description Receive active stimulation during the first 16 weeks after device implant. Receive sham stimulation during the first 16 weeks after device implant.
Period Title: Blinded-treatment Phase
Started 16 14
Completed 15 [1] 14
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
[1]
One subject did not receive the allocated intervention.
Period Title: Long-term Follow-up Phase - Open Label
Started 29 [1] 0
Completed 24 0
Not Completed 5 0
Reason Not Completed
Physician Decision             2             0
Withdrawal by Subject             2             0
Death             1             0
[1]
All subjects received open-label stimulation during this phase.
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation Total
Hide Arm/Group Description Receive active stimulation during the first 16 weeks after device implant. Receive sham stimulation during the first 16 weeks after device implant. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
All enrolled participants are included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
46.6  (14.4) 48.9  (8.9) 47.7  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
8
  50.0%
5
  35.7%
13
  43.3%
Male
8
  50.0%
9
  64.3%
17
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
Baseline depression score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 14 participants 30 participants
37.0  (5.1) 36.4  (3.3) 36.7  (4.3)
[1]
Measure Description: Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression)
1.Primary Outcome
Title Responders
Hide Description Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.
Time Frame Baseline to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation
Hide Arm/Group Description:
Receive active stimulation during the first 16 weeks after device implant.
Receive sham stimulation during the first 16 weeks after device implant.
Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: participants
3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group-Active Stimulation, Control Group-Sham Stimulation
Comments The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.53
Comments

one-sided P-value

per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%

Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Depression Change
Hide Description Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change).
Time Frame Baseline to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation
Hide Arm/Group Description:
Receive active stimulation during the first 16 weeks after device implant.
Receive sham stimulation during the first 16 weeks after device implant.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-19.6  (34.9) -24.6  (28.8)
3.Secondary Outcome
Title Quality of Life Change
Hide Description Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change).
Time Frame Baseline to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation
Hide Arm/Group Description:
Receive active stimulation during the first 16 weeks after device implant.
Receive sham stimulation during the first 16 weeks after device implant.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: change from baseline score
10.2  (24.8) 9.8  (18.8)
4.Other Pre-specified Outcome
Title Long-term Open-label Responders
Hide Description This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.
Time Frame at the 24-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders.
Arm/Group Title Long-term Open-label Treatment
Hide Arm/Group Description:
All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
7
5.Other Pre-specified Outcome
Title Therapy-related Adverse Events
Hide Description Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.
Time Frame from enrollment to study closure (average follow-up of 36 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants are included in the analysis.
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description:
The 30 subjects were followed an average of 36 months after enrollment.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Device - Implant site pain 7
Device - Paraesthesia 4
Procedure - Implant site pain 8
Procedure - Implant site infection 5
Procedure - Dermatitis contact 2
Procedure - Face oedema 2
Procedure - Headache 2
Procedure - Hypersensitivity 2
Stimulation - Insomnia 15
Stimulation - Depression 8
Stimulation - Hypomania 8
Stimulation - Irritability 8
Stimulation - Anxiety 7
Stimulation - Fatigue 6
Stimulation - Headache 6
Stimulation - Agitation 5
Stimulation - Sleep disorder 5
Stimulation - Disturbance in attention 4
Stimulation - Suicidal ideation 4
Stimulation - Disinhibition 3
Stimulation - Memory impairment 3
Stimulation - Paraesthesia 3
Stimulation - Energy increased 2
Stimulation - Impulsive behaviour 2
Stimulation - Nausea 2
Stimulation - Thinking abnormal 2
Stimulation - Weight increased 2
Time Frame 16 weeks
Adverse Event Reporting Description Adverse event results for the blinded-treatment phase only. All randomized subjects were included in adverse event summaries.
 
Arm/Group Title Active Group-Active Stimulation Control Group-Sham Stimulation
Hide Arm/Group Description Receive active stimulation during the first 16 weeks after device implant. Receive sham stimulation during the first 16 weeks after device implant.
All-Cause Mortality
Active Group-Active Stimulation Control Group-Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Group-Active Stimulation Control Group-Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   4/16 (25.00%)   4/14 (28.57%) 
Infections and infestations     
Wound infection staphylococcal  1  0/16 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications     
Neurostimulator protrusion  1  0/16 (0.00%)  1/14 (7.14%) 
Psychiatric disorders     
Depression  1  1/16 (6.25%)  3/14 (21.43%) 
Suicidal ideation  1  1/16 (6.25%)  0/14 (0.00%) 
Disinhibition  1  1/16 (6.25%)  0/14 (0.00%) 
Vascular disorders     
Femoral arterial stenosis  1  1/16 (6.25%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Group-Active Stimulation Control Group-Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   15/16 (93.75%)   14/14 (100.00%) 
Ear and labyrinth disorders     
Tinnitus  1  0/16 (0.00%)  1/14 (7.14%) 
Eye disorders     
Eye pain  1  1/16 (6.25%)  0/14 (0.00%) 
Ocular hyperaemia  1  1/16 (6.25%)  0/14 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/16 (6.25%)  0/14 (0.00%) 
Dysphagia  1  1/16 (6.25%)  0/14 (0.00%) 
Toothache  1  1/16 (6.25%)  0/14 (0.00%) 
Constipation  1  0/16 (0.00%)  1/14 (7.14%) 
General disorders     
Implant site pain  1  4/16 (25.00%)  2/14 (14.29%) 
Fatigue  1  3/16 (18.75%)  0/14 (0.00%) 
Drug withdrawal syndrome  1  1/16 (6.25%)  1/14 (7.14%) 
Energy increased  1  1/16 (6.25%)  0/14 (0.00%) 
Allodynia  1  0/16 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Influenza  1  1/16 (6.25%)  1/14 (7.14%) 
Upper respiratory tract infection  1  2/16 (12.50%)  0/14 (0.00%) 
Gastroenteritis viral  1  1/16 (6.25%)  1/14 (7.14%) 
Localised infection  1  0/16 (0.00%)  2/14 (14.29%) 
Fungal infection  1  0/16 (0.00%)  1/14 (7.14%) 
Nasopharyngitis  1  0/16 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications     
Fall  1  1/16 (6.25%)  3/14 (21.43%) 
Animal bite  1  0/16 (0.00%)  1/14 (7.14%) 
Back injury  1  0/16 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Bunion  1  1/16 (6.25%)  0/14 (0.00%) 
Bursitis  1  0/16 (0.00%)  1/14 (7.14%) 
Muscle spasms  1  0/16 (0.00%)  1/14 (7.14%) 
Osteoarthritis  1  0/16 (0.00%)  1/14 (7.14%) 
Rotator cuff syndrome  1  0/16 (0.00%)  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1  1/16 (6.25%)  0/14 (0.00%) 
Nervous system disorders     
Headache  1  2/16 (12.50%)  1/14 (7.14%) 
Tremor  1  1/16 (6.25%)  1/14 (7.14%) 
Cognitive disorder  1  1/16 (6.25%)  0/14 (0.00%) 
Hypersomnia  1  1/16 (6.25%)  0/14 (0.00%) 
Hyporeflexia  1  1/16 (6.25%)  0/14 (0.00%) 
Somnolence  1  1/16 (6.25%)  0/14 (0.00%) 
Transient ischaemic attack  1  1/16 (6.25%)  0/14 (0.00%) 
Balance disorder  1  0/16 (0.00%)  1/14 (7.14%) 
Paraesthesia  1  0/16 (0.00%)  1/14 (7.14%) 
Restless legs syndrome  1  0/16 (0.00%)  1/14 (7.14%) 
Psychiatric disorders     
Depression  1  4/16 (25.00%)  0/14 (0.00%) 
Insomnia  1  4/16 (25.00%)  3/14 (21.43%) 
Irritability  1  3/16 (18.75%)  0/14 (0.00%) 
Suicidal ideation  1  1/16 (6.25%)  0/14 (0.00%) 
Disinhibition  1  1/16 (6.25%)  0/14 (0.00%) 
Hypomania  1  2/16 (12.50%)  0/14 (0.00%) 
Sleep disorder  1  1/16 (6.25%)  1/14 (7.14%) 
Mania  1  1/16 (6.25%)  0/14 (0.00%) 
Early morning awakening  1  0/16 (0.00%)  1/14 (7.14%) 
Purging  1  0/16 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders     
Adnexa uteri mass  1  1/16 (6.25%)  0/14 (0.00%) 
Menstruation irregular  1  0/16 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/16 (6.25%)  0/14 (0.00%) 
Sinus congestion  1  1/16 (6.25%)  0/14 (0.00%) 
Upper respiratory tract congestion  1  0/16 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Hypertension  1  3/16 (18.75%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparisons of response rates and improvements were not adequately powered.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
Results Point of Contact
Name/Title: Eric Williamson, Clinical Evidence Specialist
Organization: Medtronic Neuromodulation
Phone: 763-526-7982
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00837486     History of Changes
Other Study ID Numbers: 1626
G080033
First Submitted: February 3, 2009
First Posted: February 5, 2009
Results First Submitted: March 13, 2015
Results First Posted: May 28, 2015
Last Update Posted: May 28, 2015