Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment

NCT07887737 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STU20260854
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period. During this trial we aim to demonstrate the safety of acute and chronic network-guided stimulation in Mild Cognitive Impairment by evaluating adverse effects, tolerability, and feasibility during both the short- term SEEG mapping phase and subsequent permanent DBS therapy. In addition to safety measures, therapeutic results as follows are to be tested for: (1) Develop patient-specific stimulation parameters for the treatment of MCI, as well as develop and test memory state classifiers by enrolling six individuals to undergo intracranial mapping (SEEG). We will use targeted memory tasks to generate neural data needed for state distinctions, and conduct a systematic parameter search to identify and develop optimal settings for each patient. (2) Assess efficacy of open loop stimulation by delivering a fixed open loop protocol based on the parameters discovered earlier, while SEEG electrodes remain in place, and testing the efficacy of the trained classifier to detect favorable brain states. (3) Evaluate chronic DBS therapy by implanting a permanent system in participants who show an acute beneficial response to assess long term outcomes. (4) Assess therapeutic outcomes and refine protocols by measuring reductions in memory-related impairment. The above findings will guide further refinement of the device and protocol.

Conditions

Mild Cognitive Impairment (MCI); Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease; Memory Deficit; Memory Disorder; Mild Cognitive Impairment (MCI) Amnestic

Keywords

Deep Brain Stimulation; Neuromodulation of Memory; Memory Disorder; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Demonstrate device safety

  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.

  4 years

Secondary Outcomes (16)

• RCI - ECog

  Week 35-39 (3-6 weeks post-intervention)

• RCI - ECog

  Week 41-44 (9-12 weeks post-intervention)

• RCI - GAD-7

  Week 35-39 (3-6 weeks post-intervention)

• RCI - GAD-7

  Week 41-44 (9-12 weeks post-intervention)

• RCI - NPI-Q

  Week 35-39 (3-6 weeks post-intervention)]

Study Arms (2)

Deactivation of Stimulation with the Abbott St Jude Medical Infinity™

PLACEBO COMPARATOR

Subjects will be deactivated (stimulation no longer occurs) from stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur.

Device: Abbott St Jude Medical Infinity™

Stimulation Continuation with Abbott St Jude Medical Infinity™

EXPERIMENTAL

Subjects will continue stimulation (stimulation occurs) with the Abbott St Jude Medical Infinity™ based on parameters developed in the inpatient stay. Weekly assessments on primary memory measures will occur.

Device: Abbott St Jude Medical Infinity™

Interventions

Abbott St Jude Medical Infinity™ DEVICE

Subjects will be deactivated (stimulation no longer occurs) from stimulation/ continue stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur.

Deactivation of Stimulation with the Abbott St Jude Medical Infinity™; Stimulation Continuation with Abbott St Jude Medical Infinity™

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (non-pregnant) between ages 60 and 85.
• Meets NIA-AA core clinical criteria for MCI due to Alzheimer's Disease.
• Determination by the investigator, based on clinical judgment and review of medical history, neurological examination, cognitive profile, and available clinical data, that Alzheimer's Disease is the primary suspected etiology.
• Absence of other psychiatric or physical conditions that could interfere with the study.
• Stable medication regimen for 4 weeks preceding surgery; participants currently receiving anti-amyloid therapies may enroll if they are able and willing to pause infusions for at least 12 weeks prior to study initiation and for the duration of the study.
• Other medical conditions must be stable for at least 6 months prior to SEEG Implantation.
• Able and willing to give informed consent or have a Legally Authorized Representative who is able to sign the informed consent form.
• Able to have a study partner(s) or close relative(s) present for discussions about the study

You may not qualify if:

• Active alcohol or substance use disorder within 6 months of entering the Screening Phase, excluding nicotine. Urine drug test positive for illicit drugs.
• Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation).
• Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, neuro-developmental disorder , or other factors that predispose seizures such as an active eating disorder).
• Cognitive symptoms that are not be better explained by delirium, unstable psychiatric illness, active substance use disorder, major untreated sleep disorder, acute neurologic illness, or other medical condition that, in the investigator's judgment, is the primary cause of the impairment.
• Brain structural MRI abnormalities outside of expected pathology associated with Mild Cognitive Impairment.
• Any medical contraindication to surgery such as infection.
• Coagulopathy: Bleeding propensity and/or one of the following: INR \> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \< 100×103 /uL
• Uncontrolled hypertension (systolic \> 145mmHg and/or diastolic \> 90 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the participant is taking antihypertensive medications.
• Participation in another drug, device, or biological study within 90 days.
• Current implanted neural stimulation devices including spinal cord stimulators and deep brain stimulators.
• Need for Diathermy.
• Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period.
• Any Psychiatric/Neurological/Medical condition that makes the participant, in the opinion of the Investigator, a poor candidate. These may be but are not limited to a DSM-5 diagnosis of schizophrenia, bipolar disorder, obsessive-compulsive disorder.
• Moderate to severe depressive symptoms, defined as a GDS-15 score ≥11 at screening, or investigator judgment that depressive symptoms are unstable, severe, or likely to interfere with study participation or interpretation of cognitive outcomes.
• High risk of suicide, defined as any of the following on the Columbia Suicide Severity Rating Scale (C-SSRS) short form at screening: active suicidal ideation with intent to act, active suicidal ideation with a specific plan and intent, suicidal behavior within the past 3 months or investigator judgment that the participant is at imminent or clinically significant risk for self-harm.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradley Lega, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Brendan Kelley, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley Lega, MD

CONTACT

214-648-7816; Bradley.Lega@UTSouthwestern.edu

Tash Mupambo, MS

CONTACT

Tash.Mupambo@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor

Model Details: Open-Label Optimization During the first 8 months of the clinical trial, we will program the device and monitor for changes in symptoms in an open-label fashion, with no blinding. All the participants will be evaluated at the end of the open label period (Week 32). DOUBLE-BLIND DISCONTINUATION (Week 33 - Week 45) Both responders and non-responders will enter a double-blind discontinuation period. Total anticipated duration of this portion of the study is up to 12 weeks. * 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.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share