Trial · NCT07887737
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Demonstrate device safety | 4 years | Description: The primary objective is to demonstrate safety of acute and chronic network guided stimulation for Mild Cognitive Impairment (MCI). This is determined if participants with the Deep Brain Stimulation Device demonstrate no significant device related serious adverse events (SAE). Device safety will be measured by number of reported SAE's in years 2 through 4. |
| Secondary | RCI - ECog | Week 35-39 (3-6 weeks post-intervention) | The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - ECog | Week 41-44 (9-12 weeks post-intervention) | The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - GAD-7 | Week 35-39 (3-6 weeks post-intervention) | General Anxiety Disorder-7 ( (GAD-7). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - GAD-7 | Week 41-44 (9-12 weeks post-intervention) | General Anxiety Disorder-7 ( (GAD-7). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - NPI-Q | Week 35-39 (3-6 weeks post-intervention)] | Neuropsychiatric Inventory Questionnaire (NPI-Q). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The neuropsychiatric inventory questionnaire score, which includes 12 items that assesses a broad range of psychiatric disturbances associated with: (1) delusions; (2) hallucinations; (3) agitation or aggression; (4) depression or dysphoria; (5) anxiety; (6) elation or euphoria; (7) apathy or indifference; (8) disinhibition; (9) irritability or lability; (10) motor disturbance; (11) nighttime behaviors; and (12) appetite and eating, is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96 |
| Secondary | RCI - NPI-Q | Week 41-44 (9-12 weeks post-intervention) | Neuropsychiatric Inventory Questionnaire (NPI-Q). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The neuropsychiatric inventory questionnaire score, which includes 12 items that assesses a broad range of psychiatric disturbances associated with: (1) delusions; (2) hallucinations; (3) agitation or aggression; (4) depression or dysphoria; (5) anxiety; (6) elation or euphoria; (7) apathy or indifference; (8) disinhibition; (9) irritability or lability; (10) motor disturbance; (11) nighttime behaviors; and (12) appetite and eating, is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96 |
| Secondary | RCI - CGI-S | Week 35-39 (3-6 weeks post-intervention) | Clinical Global Impression Severity Scale (CGI-S). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point (1-7) scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention with the higher scores indicating higher symptom severity. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - CGI-S | Week 41-44 (9-12 weeks post-intervention) | Clinical Global Impression Severity Scale (CGI-S). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point (1-7) scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention with the higher scores indicating higher symptom severity. • Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - CDR | Week 35-39 (3-6 weeks post-intervention) | Global Clinical Dementia Rating (CDR). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - CDR | Week 41-44 (9-12 weeks post-intervention) | Global Clinical Dementia Rating (CDR). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - MADRS | Week 35-39 (3-6 weeks post-intervention) | Montgomery-Åsberg Depression Rating Scale (MADRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes and monitor patient progress during treatment. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60.\[4\] Higher MADRS score indicates more severe depression. Usual cutoff points are: 0 to 6: normal /symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression 35 to 60: severe depression. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - MADRS | Week 41-44 (9-12 weeks post-intervention) | Montgomery-Åsberg Depression Rating Scale (MADRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes and monitor patient progress during treatment. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60.\[4\] Higher MADRS score indicates more severe depression. Usual cutoff points are: 0 to 6: normal /symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression 35 to 60: severe depression. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - C-SSRS | Week 35-39 (3-6 weeks post-intervention) | Columbia-Suicide Severity Rating Scale (C-SSRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, evidence-based tool used to screen for suicide risk, measure the severity of suicidal ideation, and track suicidal behavior. Screening versions typically group responses into general clinical risk categories: • No Risk / Score 0: No ideation or behavior reported. • Low Risk (e.g., Categories 1-2): Wish to be dead or non-specific active thoughts. • Moderate Risk (e.g., Category 3 or interrupted/aborted) Method without plan • High Risk (e.g., Categories 4-5, actual attempts, detailed plan): Active intent/plan. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - C-SSRS | Week 41-44 (9-12 weeks post-intervention) | Columbia-Suicide Severity Rating Scale (C-SSRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, evidence-based tool used to screen for suicide risk, measure the severity of suicidal ideation, and track suicidal behavior. Screening versions typically group responses into general clinical risk categories: • No Risk / Score 0: No ideation or behavior reported. • Low Risk (e.g., Categories 1-2): Wish to be dead or non-specific active thoughts. • Moderate Risk (e.g., Category 3 or interrupted/aborted) Method without plan • High Risk (e.g., Categories 4-5, actual attempts, detailed plan): Active intent/plan. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - MoCA | Week 35-39 (3-6 weeks post-intervention) | Montreal Cognitive Assessment (MoCA) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montreal Cognitive Assessment (MoCA) is a quick 30-point test used by health professionals to screen adults for mild memory and thinking problems. MoCA Normal and Mild cognitive impairment score ranges were derived from the JAGS 2005 MoCA Validation study where MoCA MCI score ranges were defined by Petersons' Criteria. The moderate and severe groups were arbitrary defined by default as: Normal Cognitive performance 26 and above; Mild impairment 18-25; Moderate impairment 10-17; Severe impairment 0-9 * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
| Secondary | RCI - MoCA | Week 41-44 (9-12 weeks post-intervention) | Montreal Cognitive Assessment (MoCA) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montreal Cognitive Assessment (MoCA) is a quick 30-point test used by health professionals to screen adults for mild memory and thinking problems. MoCA Normal and Mild cognitive impairment score ranges were derived from the JAGS 2005 MoCA Validation study where MoCA MCI score ranges were defined by Petersons' Criteria. The moderate and severe groups were arbitrary defined by default as: Normal Cognitive performance 26 and above; Mild impairment 18-25; Moderate impairment 10-17; Severe impairment 0-9 * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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