Deep Brain Stimulation for Memory Impairments

Overseen By Sonja Hiller

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Non-native English speaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 days per year

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand the neural mechanisms that support real world spatial navigation in humans using deep brain recordings and stimulation during virtual reality (VR), augmented reality, and real world memory tasks. We will determine the cognitive (i.e., memory) and behavioral (i.e., body, head, eye position and movement) factors that modulate deep brain activity and the consequent effects of memory-enhancing deep brain stimulation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Deep Brain Stimulation for Memory Impairments?

Research shows that Deep Brain Stimulation (DBS) has been effective in treating movement disorders like Parkinson's disease and has shown promise in enhancing memory and cognitive functions. Studies suggest that DBS can modulate brain circuits involved in memory, potentially benefiting conditions like Alzheimer's disease by targeting specific brain areas such as the fornix and nucleus basalis of Meynert. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections, lead migrations (movement of the wires), and device malfunctions, with some cases requiring additional surgery. Overall, serious complications occur in a small percentage of cases. ^{6 7 8 9 10}

How does deep brain stimulation differ from other treatments for memory impairments?

Deep brain stimulation (DBS) is unique because it involves a surgical procedure to implant a device that sends electrical impulses to specific areas of the brain, targeting memory circuits. Unlike other treatments, DBS is reversible, adjustable, and non-ablative, and it has shown promise in modulating brain activity to improve memory and cognitive functions, particularly in conditions like Alzheimer's disease where standard treatments are lacking. ^{2 3 4 5 11}

Research Team

Nanthia Suthana, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults over 18 who can read and write English fluently, have given informed consent, and already have an RNS (Responsive Neurostimulation) system placed. It's not suitable for those who are unwilling to consent or are non-native English speakers.

Inclusion Criteria

I am over 18 and have had an RNS system placed.

Ability to read and write English fluently

Willing to provide informed consent and participate in the study

Exclusion Criteria

Unwilling to provide informed consent

English is not my first language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo deep brain recordings and stimulation during virtual reality, augmented reality, and real-world memory tasks

2-4 days per year

Follow-up

Participants are monitored for changes in spatial memory, memory performance, and oscillatory activity

2-4 days per year

Treatment Details

Interventions

• Deep Brain Recordings
• Deep Brain Stimulation

Trial Overview The study aims to understand how the brain supports real-world spatial navigation using VR, augmented reality, and memory tasks by observing deep brain activity and testing memory-enhancing brain stimulation.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

Deep brain stimulation (DBS) targeting the nucleus basalis of Meynert shows promise in enhancing cognitive function and potentially slowing the progression of Alzheimer's disease, based on recent human and animal studies.

The effectiveness of DBS may depend on stimulation parameters, with lower frequencies or intermittent patterns likely being more beneficial for cognitive enhancement compared to the high-frequency stimulation used for movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholinergic Deep Brain Stimulation for Memory and Cognitive Disorders. Subramaniam, S., Blake, DT., Constantinidis, C.[2023]

Bilateral hypothalamic deep brain stimulation in a patient with morbid obesity unexpectedly enhanced detailed autobiographical memory recall, suggesting a link between hypothalamic stimulation and memory functions.

The stimulation specifically increased recollection without affecting familiarity-based recognition, indicating that it engages the hippocampus and modulates limbic activity, as confirmed by electroencephalographic source localization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Hamani, C., McAndrews, MP., Cohn, M., et al.[2022]

High-frequency deep brain stimulation (DBS) has been safely and effectively used to treat over 100,000 patients with movement disorders since its introduction in the late 1980s, supported by numerous clinical trials.

Recent studies are exploring the potential of DBS to modulate memory in neurodegenerative disorders like Alzheimer's disease, indicating its possible application beyond just motor circuit disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Alzheimer's Disease. Xu, DS., Ponce, FA.[2018]

Deep brain stimulation (DBS) is a promising neurosurgical treatment that has shown effectiveness in modulating disrupted neural circuits, which could be beneficial for patients with Alzheimer's disease and other cognitive disorders.

Current research is exploring the use of DBS to target specific areas in the brain associated with memory, such as the fornix and nucleus basalis of Meynert, as a novel approach to address the growing challenge of cognitive decline in the aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for disorders of memory and cognition. Sankar, T., Lipsman, N., Lozano, AM.[2021]

Deep brain stimulation (DBS) has been shown to effectively treat various neurological and neuropsychiatric disorders, including Parkinson's disease and depression, and may also enhance memory related to the medial temporal lobe, suggesting potential for treating memory disorders like Alzheimer's disease.

The review discusses the mechanisms of how DBS can improve memory and outlines future research directions needed to explore its therapeutic applications for memory-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for enhancement of learning and memory. Suthana, N., Fried, I.[2021]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

In a study of 200 patients undergoing deep brain stimulation (DBS) procedures over a follow-up period of approximately 43 months, 20% experienced surgical or hardware-related adverse events (AEs), but all resolved without permanent effects.

The most common AEs were surgical site infections (9.95%) and wire tethering (2.49%), indicating that while AEs can occur, major complications requiring further surgery are rare, highlighting the overall safety of DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. Bouwens van der Vlis, TAM., van de Veerdonk, MMGH., Ackermans, L., et al.[2022]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

A systematic review of 96 studies found that the most common complications from Deep Brain Stimulation (DBS) procedures include infections (5.12% of patients) and lead migration (1.60%), highlighting the importance of monitoring for these issues post-surgery.

Patients with conditions like dystonia and off-label indications such as Tourette's syndrome are at a higher risk for hardware-related complications, suggesting that these patients should receive thorough pre-surgical counseling and close follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? Jitkritsadakul, O., Bhidayasiri, R., Kalia, SK., et al.[2022]

Deep brain stimulation (DBS) has shown promising results in early Phase I clinical trials for Alzheimer's disease, improving cognitive function and reducing brain atrophy in patients.

Animal studies support these findings, demonstrating that DBS can enhance neuroplasticity and memory performance, although the exact mechanisms and clinical efficacy are still being investigated in ongoing trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale for deep brain stimulation in Alzheimer's disease. Mirzadeh, Z., Bari, A., Lozano, AM.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cholinergic Deep Brain Stimulation for Memory and Cognitive Disorders. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Memory enhancement induced by hypothalamic/fornix deep brain stimulation. [2022]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Alzheimer's Disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for disorders of memory and cognition. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for enhancement of learning and memory. [2021]

6. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? [2022]

11. Austria pubmed.ncbi.nlm.nih.gov

The rationale for deep brain stimulation in Alzheimer's disease. [2022]