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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how deep brain stimulation (DBS) might improve memory by examining brain activity during virtual reality and real-world tasks. Researchers seek to understand how the brain controls memory and movement and how stimulation can enhance these functions. Individuals with an implanted RNS system who can read and write English fluently might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on memory enhancement.

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 prior data suggests that deep brain stimulation and recordings are safe for memory impairments?

Research has shown that deep brain stimulation (DBS) is generally safe for people. In one study, patients experienced no serious side effects from DBS; instead, they showed improved thinking skills and a better quality of life. DBS involves placing small electrodes in the brain to send electrical signals that alter brain activity. The FDA has already approved this method for treating conditions like Parkinson's disease, indicating a strong safety record. Overall, DBS appears safe based on current research, with no major safety issues reported in existing studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for memory impairments focus on medication or cognitive therapy to help manage symptoms. However, deep brain stimulation is unique because it directly targets brain activity by using electrical impulses to stimulate specific areas of the brain involved in memory. Unlike traditional methods, which often work indirectly, this technique aims to enhance memory function by directly interacting with the brain's electrical patterns. Researchers are excited about this approach because it could offer more immediate and potentially more effective improvements in memory function compared to existing treatments.

What evidence suggests that deep brain stimulation is effective for memory impairments?

Research has shown that deep brain stimulation (DBS) could improve memory in individuals with memory-related issues such as dementia. Studies have found that the effects of DBS on memory vary depending on the targeted brain region. DBS alters brain activity, potentially enhancing memory. Early research suggests that DBS might be particularly effective for memory problems when focused on specific areas like the fornix. Overall, DBS appears promising for boosting memory by targeting certain brain activities. ^{6 7 8 9 10}

Who Is on the Research Team?

Nanthia Suthana, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Willing to provide informed consent and participate in the study

Ability to read and write English fluently

Exclusion Criteria

Unwilling to provide informed consent

English is not my first language.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6961776/

The Paradoxical Effect of Deep Brain Stimulation on Memory Deep brain stimulation (DBS) is a promising treatment for many memory-related disorders including dementia, anxiety, and addiction.

2. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70498

Cognitive outcomes of deep brain stimulation depend on age ... Deep brain stimulation in PD and AD can result in opposite cognitive outcomes. Top panel, 33 PD patients receiving subthalamic nucleus deep ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923008772

Deep Brain Stimulation for Disorders of Memory and ... DBS has proven to be an effective means of modulating activity in disrupted motor circuitry, and has shown promise as a modulator of other dysfunctional ...

4. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/articles/mapping-cognitive-effects-of-deep-brain-stimulation

Mapping Cognitive Effects of Deep Brain Stimulation DBS can either improve or worsen cognition in patients with Parkinson's or Alzheimer's, depending on a few key factors. When the hippocampus is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06818864

DBS for Cognitive Deficits After Traumatic Brain Injury Preclinical studies suggest that DBS may improve memory deficits in TBI models. Moreover, DBS delivered to the fornix has shown promising ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004396/

Efficacy and Safety of Bilateral Deep Brain Stimulation ... All patients tolerated DBS well, with no serious adverse effects reported. Early on, DBS significantly improved cognitive function and quality ...

7. mayoclinic.org mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562

Deep brain stimulation Deep brain stimulation (DBS) involves implanting electrodes within areas of the brain. The electrodes produce electrical impulses that affect brain activity.

8. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/deep-brain-stimulation

Deep Brain Stimulation DBS surgery is an FDA-approved treatment for Parkinson's disease, and Medicare and most private insurers cover the procedure, but the extent of coverage will ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S187887502301817X

Deep Brain Stimulation as an Emerging Therapy for ... In 5 of 6 patients, DBS-f improved cognitive scores or less than expected rate of decline at 6 and 12 months.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT00947934

Study of the Brain Stimulation Effect on Memory Impairment ... The primary objectives of this prospective, non-controlled, pilot study are to evaluate the feasibility and safety of DBS in AD patients with mild cognitive and ...