Trial Outcomes & Findings for Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression (NCT NCT03360942)

Last Updated: 2024-12-12

Results Overview

Patients will be evaluated every 12 months by the study psychiatrist (via in-person, phone or video call visit) to assess device functioning,

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.

Results posted on

2024-12-12

Participant Flow

5 participants were in a prior study (NCT01898429) to receive Deep Brain Stimulation (DBS) and were asked to enroll to have their progress and DBS devices monitored for a period of 12 years.

Participant milestones

Participant milestones
Measure	DBS Long Term Follow Up Participants with Deep Brain Stimulation for Treatment-Resistant Depression
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	DBS Long Term Follow Up Participants with Deep Brain Stimulation for Treatment-Resistant Depression
Overall Study Device explanted	2
Overall Study Study closure	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBS Long Term Follow Up n=5 Participants Participants with Deep Brain Stimulation for Treatment-Resistant Depression
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.

Population: One participant had the device explanted after one year of follow-up, and thus the number analyzed dropped from 5 to 4 after the first year. After the 5th year assessment, one additional participant had the device explanted, and one participant withdrew from participation dropping the number of participants analyzed from 4 to 2. The study was closed after the sixth year.

Patients will be evaluated every 12 months by the study psychiatrist (via in-person, phone or video call visit) to assess device functioning,

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=5 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Device Was Functioning Year 1 · Yes Functioning	3 Participants
Device Was Functioning Year 1 · No, Not Functioning	1 Participants
Device Was Functioning Year 1 · Unknown (No data recorded regarding status of device)	1 Participants
Device Was Functioning Year 2 · Yes Functioning	2 Participants
Device Was Functioning Year 2 · No, Not Functioning	0 Participants
Device Was Functioning Year 2 · Unknown (No data recorded regarding status of device)	2 Participants
Device Was Functioning Year 3 · Yes Functioning	1 Participants
Device Was Functioning Year 3 · No, Not Functioning	0 Participants
Device Was Functioning Year 3 · Unknown (No data recorded regarding status of device)	3 Participants
Device Was Functioning Year 4 · Yes Functioning	1 Participants
Device Was Functioning Year 4 · No, Not Functioning	0 Participants
Device Was Functioning Year 4 · Unknown (No data recorded regarding status of device)	3 Participants
Device Was Functioning Year 5 · Yes Functioning	1 Participants
Device Was Functioning Year 5 · No, Not Functioning	0 Participants
Device Was Functioning Year 5 · Unknown (No data recorded regarding status of device)	3 Participants
Device Was Functioning Year 6 · Yes Functioning	0 Participants
Device Was Functioning Year 6 · No, Not Functioning	0 Participants
Device Was Functioning Year 6 · Unknown (No data recorded regarding status of device)	2 Participants

PRIMARY outcome

Population: In year 1, confirmation of psychiatrist oversight or completion of assessment could not be verified for 3 of 5 participants. One participant had device explanted after year 1 and no data was collected for this participant thereafter. Data for 2 of 4 participants were not collected utilizing this tool after year 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for year 2. No data was collected utilizing this assessment after year 2.

The Hamilton Depression Rating Scale-17 (HDRS-17) is a 17-item clinician-administered depression assessment scale pertaining to symptoms of depression experienced over the past week. For the HDRS-17, a score of 0-7 is generally accepted to be within the normal range., a score of 8-12: Possible depression, a score of 13-17: Mild depression, a score of 18-24: Moderate depression, a score of 25-52: Severe depression.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Hamilton Depression Rating Scale (HDRS-17) Score Over Time Year 1	18 score on a scale Interval 16.0 to 20.0
Mean Hamilton Depression Rating Scale (HDRS-17) Score Over Time Year 2	24 score on a scale Interval 24.0 to 24.0

PRIMARY outcome

The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-21) is a 21-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 21 items assessing various aspects of depression, including mood, guilt, insomnia, agitation \& anxiety. Participants are rated on each item based on the presence \& severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms \& the scores from those 17 items are combined to create a total score (52 max). Higher total scores indicate more severe depression, with ranges typically interpreted as follows: a score of 0-7 is generally accepted to be within the normal range (Minimal or no depression), a score of 8-13: Mild depression, a score of 14-18: Moderate depression, a score of 19-22: Severe depression, a score of 23 and above: very severe depression. The sum of all 21 items results in highest possible score of 76.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Hamilton Depression Rating Scale-21 (HDRS-21) Score Over Time Year 1	22 units on a scale Interval 20.0 to 24.0
Mean Hamilton Depression Rating Scale-21 (HDRS-21) Score Over Time Year 2	25 units on a scale Interval 25.0 to 25.0

PRIMARY outcome

The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-24) is a 24-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 24 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-24 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (sever depression) and 23 or higher (very severe depression). The sum of the scores from all 24 items results in the highest possible score being 78.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Hamilton Depression Rating Scale-24 (HDRS-24) Score Over Time Year 1	29.5 score on a scale Interval 27.0 to 32.0
Mean Hamilton Depression Rating Scale-24 (HDRS-24) Score Over Time Year 2	28 score on a scale Interval 28.0 to 28.0

PRIMARY outcome

The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-28) is a 28-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 28 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-28 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (Sever depression) and 23 or higher (very severe depression). The sum of the scores from all 28 items results in the total score, with the highest possible score being 84.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Hamilton Depression Rating Scale-28 (HDRS-28) Score Over Time Year 1	32.5 score on a scale Interval 30.0 to 35.0
Mean Hamilton Depression Rating Scale-28 (HDRS-28) Score Over Time Year 2	31 score on a scale Interval 31.0 to 31.0

PRIMARY outcome

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 10 items that assess various symptoms of depression, including apparent sadness, reported sadness, inner tension, sleep disturbances, and reduced appetite. Each item is rated on a scale from 0 to 6, with higher scores indicating more severe symptoms. The total score on the MADRS ranges from 0 to 60, with higher scores reflecting greater severity of depression. Interpretation of MADRS scores is as follows: 0-6 (normal), 7-19 (mild depression), 20-34 (moderate depression), and 35 or higher (severe depression).

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over Time Year 1	25 score on a scale Interval 24.0 to 26.0
Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over Time Year 2	25 score on a scale Interval 25.0 to 25.0

PRIMARY outcome

Population: 1 of 5 participants did not have this data collected at any time. In year 1, confirmation of psychiatrist oversight/completion of assessment could not be verified for 3 of 4 participants. After year 1, data for 2 participants were not collected. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for year 2. No data was collected after year 2.

The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items, each of which assesses a different symptom of anxiety. These items cover both psychological and physical manifestations of anxiety. Each item is scored on a scale from 0 to 4, with 0 indicating the absence of the symptom and 4 indicating severe or disabling symptoms. The total score can range from 0 to 56, with higher scores indicating more severe anxiety.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Hamilton Anxiety Rating Scale Over Time Year 1	25 units on a scale Interval 25.0 to 25.0
Mean Hamilton Anxiety Rating Scale Over Time Year 2	25 units on a scale Interval 25.0 to 25.0

PRIMARY outcome

The Young Mania Rating Scale (YMRS) is a clinical assessment tool designed to measure the severity of manic symptoms in individuals diagnosed with bipolar disorder. The scale consists of an 11-item scale used to assess the severity of manic states, including elevated mood, increased energy levels, irritability, impulsivity, and grandiosity. Four items are graded on a scale of 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a scale of 0 to 4. Higher scores indicating more severe manic symptoms. The total score on the YMRS ranges from 0 to 60, with higher scores reflecting greater severity of mania. Interpretation of YMRS scores is as follows: 0-12 (normal), 13-20 (mild mania), 21-35 (moderate mania), and 36 or higher (severe mania).

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Young Mania Rating Scale (YMRS) Score Over Time Year 1	0 score on a scale Interval 0.0 to 0.0
Mean Young Mania Rating Scale (YMRS) Score Over Time Year 2	0 score on a scale Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.

The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms in individuals aged 13 and older. The scale consists of 21 items that measure various symptoms of depression, such as mood, pessimism, guilt, and physical symptoms. Participants rate each item based on how they have been feeling over the past two weeks, with scores ranging from 0 to 3. Higher total scores on the BDI-II indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression).

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Beck Depression Inventory-II (BDI-II) Score Over Time Year 1	36 score on a scale Interval 36.0 to 36.0
Mean Beck Depression Inventory-II (BDI-II) Score Over Time Year 2	26 score on a scale Interval 26.0 to 26.0

PRIMARY outcome

Timeframe: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or year 2 and 3 after implantation.

Population: In year 1 confirmation of psychiatrist oversight/completion of assessment could not be verified for 3 of 5 participants. 1 participant had device explanted after year 1 \& no data was collected thereafter. Data for 2 of 4 participants were not collected utilizing this tool after yr 1. In year 2 confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants. Data for 1 of 2 participants were not collected after yr 2. No data was collected after yr 3.

The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 16 items that assess nine criterion symptom domains of depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. Participants rate each item based on how they have been feeling over the past seven days, with scores ranging from 0 to 3 or 0 to 4. Higher total scores on the QIDS-SR indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-5 (no depression), 6-10 (mild depression), 11-15 (moderate depression), 16-20 (severe depression), and 21-27 (very severe depression).

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Score Over Time Year 1	16 units on a scale Interval 16.0 to 16.0
Mean Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Score Over Time Year 2	15 units on a scale Interval 15.0 to 15.0
Mean Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Score Over Time Year 3	9 units on a scale Interval 9.0 to 9.0

PRIMARY outcome

Population: 3 of 5 participants enrolled in this study did not have this data collected at any time. In year 1, confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants. Data for one participant was not collected utilizing this assessment tool after year 1. No data was collected after the second year for the entire cohort utilizing this assessment tool.

The Global Assessment of Functioning (GAF) is a single-item mental health status measure which assesses how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. Higher scores indicating better overall functioning.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Mean Global Assessment of Functioning (GAF) Score Over Time Year 1	55 units on a scale Interval 55.0 to 55.0
Mean Global Assessment of Functioning (GAF) Score Over Time Year 2	65 units on a scale Interval 65.0 to 65.0

PRIMARY outcome

Timeframe: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.

Population: 1 of 5 participants did not have this data collected at any time. 1 of 4 participants did not have this data collected in yr 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 3 participants in yr 1. 1 participant had device explanted and data for 1 of 3 participants were not collected after yr 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for yr 2. No data was collected after yr 2.

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical assessment tool used to evaluate the severity of suicidal ideation and behavior in individuals. The scale consists of several items that assess suicidal ideation, suicidal behavior, and the severity of suicidal intent. Scores on the C-SSRS are not summed to provide a total score; instead, each item is scored individually to assess presence, frequency, and severity of suicidal thoughts or actions.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=3 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Number of Participants Reporting Suicidal Behavior or Actual Attempts Using the Columbia- Suicide Severity Rating Scale (C-SSRS) Over Time Year 1	0 Participants
Number of Participants Reporting Suicidal Behavior or Actual Attempts Using the Columbia- Suicide Severity Rating Scale (C-SSRS) Over Time Year 2	0 Participants

PRIMARY outcome

Population: 2 of 5 participants did not have this data collected at any time. 1 of 3 participants did not have this data collected in year 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants in year 1. Data for 1 of 3 participants were not collected after year 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for year 2. No data was collected after year 2.

The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-S scale is used to assess the severity of illness at a specific point in time. The range of responses for the Severity of Illness section of the CGI are: Normal, not at all ill, Borderline mentally ill, Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment Year 1 · Moderately Ill	1 Participants
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment Year 1 · Mildly Ill	0 Participants
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment Year 2 · Moderately Ill	0 Participants
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment Year 2 · Mildly Ill	1 Participants

PRIMARY outcome

The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-I scale is used to assess the overall improvement or change in symptoms over time in response to treatment. The range of responses for the CGI-I are: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment Year 1 · Much improved	0 Participants
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment Year 1 · Minimally improved	1 Participants
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment Year 2 · Much improved	1 Participants
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment Year 2 · Minimally improved	0 Participants

PRIMARY outcome

Population: 2 of 5 participants did not have this data collected at any time. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 2 of 3 participants in year 1. Data for 1 of 3 participants were not collected after year 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for year 2. No data was collected after year 2.

The Patient Global Impression (PGI) is a self-reported assessment tool used to measure the overall severity of illness or improvement in symptoms from the patient's perspective. The potential responses to the PGI are Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. This outcome measure reports the number of participants for whom data was available.

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale Year 1 · Much Improved	1 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale Year 1 · Minimally Improved	0 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale Year 2 · Much Improved	0 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale Year 2 · Minimally Improved	1 Participants

PRIMARY outcome

The potential responses to the Patient Global Impressions of Severity scale are Normal, not at all ill, Borderline mentally ill , Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the PGI

Outcome measures

Outcome measures
Measure	DBS Long Term Follow Up n=2 Participants 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale Year 1 · Mildly Ill	1 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale Year 1 · Markedly Ill	0 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale Year 2 · Mildly Ill	0 Participants
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale Year 2 · Markedly Ill	1 Participants

Adverse Events

DBS Long Term Follow Up

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DBS Long Term Follow Up n=5 participants at risk 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years. DBS: Deep Brain Stimulator
Psychiatric disorders Hospitalization	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.

Other adverse events

Other adverse events
Measure	DBS Long Term Follow Up n=5 participants at risk 5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years. DBS: Deep Brain Stimulator
Psychiatric disorders Trouble Sleeping	80.0% 4/5 • Number of events 6 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Nightmares or other sleep disturbance	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Feeling drowsy or sleepy	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Feeling nervous or hyper	80.0% 4/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Musculoskeletal and connective tissue disorders Weakness or fatigue	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Irritable	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Poor memory	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Trouble concentrating	40.0% 2/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Feeling strange	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Numbness or tingling	60.0% 3/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Dizziness or faintness	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Headache	80.0% 4/5 • Number of events 7 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Eye disorders Blurred vision	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Respiratory, thoracic and mediastinal disorders Stuffy nose	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Gastrointestinal disorders Dry mouth	80.0% 4/5 • Number of events 5 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Drooling or increased salivation	20.0% 1/5 • Number of events 1 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Musculoskeletal and connective tissue disorders Muscle cramps or stiffness	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Trouble sitting still	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Tremor or shakiness	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Poor coordination or unsteadiness	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Cardiac disorders Heartbeat rapid or pounding	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Respiratory, thoracic and mediastinal disorders Trouble catching breath or hyperventilation	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Gastrointestinal disorders Nausea or vomiting	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Gastrointestinal disorders Stomach or abdominal discomfort	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Renal and urinary disorders Frequent need to urinate	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Loss of sexual interest	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Problems with sexual arousal (erection or lubrication)	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Delayed or absent orgasm	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Skin and subcutaneous tissue disorders Sweating excessively	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
General disorders Fluid retention or swelling	60.0% 3/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Metabolism and nutrition disorders Appetite decreased	20.0% 1/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Metabolism and nutrition disorders Appetite increased	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Investigations Weight gain	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Investigations Weight loss	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Immune system disorders Skin rash or allergy	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Diminished mental acuity/sharpness	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Difficulties finding words	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Apathy/Emotional Indifference	40.0% 2/5 • Number of events 3 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Dizziness when you stand up	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Injury, poisoning and procedural complications Bruising	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Skin and subcutaneous tissue disorders Hair thinning/loss	40.0% 2/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Vascular disorders Hot flashes	20.0% 1/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Clenching of teeth at night	80.0% 4/5 • Number of events 5 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Nervous system disorders Strange taste in mouth	20.0% 1/5 • Number of events 2 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Psychiatric disorders Unable to sit still	60.0% 3/5 • Number of events 4 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
Injury, poisoning and procedural complications Fall	20.0% 1/5 • Number of events 1 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.
General disorders Felt Sick	20.0% 1/5 • Number of events 1 • Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.

Additional Information

Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist

Dartmouth-Hitchcock Medical Center

Phone: 603-650-5333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place