Trial · NCT07887737
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
NCT07887737, Not applicable, Not yet recruiting, University of Texas Southwestern Medical Center
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment. Trials, record NCT07887737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
- NCT number
- NCT07887737
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 6 participants, estimated
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Memory Deficit, Memory Disorder
- Interventions
- Abbott St Jude Medical Infinity™
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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