BCI Clinical Trials Neurodegenerative
Overview
flowchart TD
BCI["BCI Technology"]
TRIALS["Clinical Trials"]
BCI -->|"enhances"| TRIALS
style BCI fill:#4fc3f7,stroke:#333,color:#000
style TRIALS fill:#81c784,stroke:#333,color:#000
This page provides a comprehensive overview of clinical trials investigating brain-computer interface (BCI) technologies for neurodegenerative diseases. BCI-based interventions represent a promising therapeutic approach["@clinicaltrialsgov"] for conditions including [Parkinson's disease](/diseases/parkinsons-disease), [Alzheimer's disease](/diseases/alzheimers-disease), [ALS](/diseases/amyotrophic-lateral-sclerosis), and [stroke](/diseases/stroke)-related neurological deficits.
Active Clinical Trials
[Parkinson's Disease](/diseases/parkinsons-disease) | Trial Name | Device/Intervention | Phase | Status | NCT Number | |------------|-------------------|-------|--------|-------------| | Neuralink PRIME Study | N1 Implant | Phase 1 | Recruiting | NCT06319728 | | Adaptive DBS for PD | Closed-loop DBS | Phase 2 | Recruiting | NCT05873964 | | Stentrode Motor Control | Synchron Stentrode | Phase 1 | Recruiting | NCT05196074 |
[Amyotrophic Lateral Sclerosis (ALS)](/diseases/amyotrophic-lateral-sclerosis) ...
BCI Clinical Trials Neurodegenerative
Overview
Mermaid diagram (expand to render)
This page provides a comprehensive overview of clinical trials investigating brain-computer interface (BCI) technologies for neurodegenerative diseases. BCI-based interventions represent a promising therapeutic approach["@clinicaltrialsgov"] for conditions including [Parkinson's disease](/diseases/parkinsons-disease), [Alzheimer's disease](/diseases/alzheimers-disease), [ALS](/diseases/amyotrophic-lateral-sclerosis), and [stroke](/diseases/stroke)-related neurological deficits.
Active Clinical Trials
[Parkinson's Disease](/diseases/parkinsons-disease) | Trial Name | Device/Intervention | Phase | Status | NCT Number | |------------|-------------------|-------|--------|-------------| | Neuralink PRIME Study | N1 Implant | Phase 1 | Recruiting | NCT06319728 | | Adaptive DBS for PD | Closed-loop DBS | Phase 2 | Recruiting | NCT05873964 | | Stentrode Motor Control | Synchron Stentrode | Phase 1 | Recruiting | NCT05196074 |
[Amyotrophic Lateral Sclerosis (ALS)](/diseases/amyotrophic-lateral-sclerosis) | Trial Name | Device/Intervention | Phase | Status | NCT Number | |------------|-------------------|-------|--------|-------------| | BrainGate2 | Utah Array | Early Phase 1 | Recruiting | NCT00912041 | | Neuralink Telepathy | N1 Implant | Phase 1 | Recruiting | NCT06319728 | | Synchron COMMANDER | Stentrode | Phase 1 | Recruiting | NCT05028261 |
[Stroke](/diseases/stroke) Rehabilitation | Trial Name | Device/Intervention | Phase | Status | NCT Number | |------------|-------------------|-------|--------|-------------| | BCI-Assisted Motor Recovery | EEG-Based BCI | Phase 2 | Recruiting | NCT05882338 | | Motor Imagery BCI Rehab | MI-BCI + FES | Phase 2 | Completed | NCT05211030 | | Closed-Loop BCI Therapy | Adaptive BCI | Phase 1 | Recruiting | NCT06006179 |
Epilepsy | Trial Name | Device/Intervention | Phase | Status | NCT Number | |------------|-------------------|-------|--------|-------------| | Responsive Neurostimulation | RNS System | Post-Market | Active | NCT00570198 | | ECoG-Based Seizure Prediction | ECoG BCI | Phase 2 | Recruiting | NCT05467878 |
Trial Phases Explained
Phase 1
Primary Goal : Safety and tolerability
Participants : Small group (10-50)
Duration : Several months
Focus : Identify adverse effects, determine safe dosage range
Phase 2
Primary Goal : Efficacy and side effects
Participants : Larger group (100-300)
Duration : Several months to years
Focus : Compare treated vs. control groups
Phase 3
Primary Goal : Confirm efficacy
Participants : Large group (1,000-3,000)
Duration : 1-4 years
Focus : Monitor adverse reactions, compare to standard treatments
Phase 4 (Post-Market)
Primary Goal : Long-term safety
Participants : Large populations
Duration : Ongoing
Focus : Long-term effects, cost-effectiveness
Key Inclusion Criteria
Typical Requirements for BCI Trials
Age : 18-75 years (varies by trial)
Diagnosis : Confirmed neurodegenerative condition
Disease Severity : Moderate to severe impairment
Cognitive Function : Able to provide informed consent
No Contraindications : No MRI incompatibilities, no active infections
Common Exclusion Criteria
Psychiatric Disorders : Active severe depression or psychosis
Cognitive Impairment : MMSE score below threshold
Seizure History : Active epilepsy (for some trials)
Metal Implants : MRI-incompatible devices
Pregnancy : Current pregnancy or planning pregnancy
Outcome Measures
Primary Endpoints
Communication Speed : Words per minute (for communication BCIs)
Motor Function : Fugl-Meyer Assessment, Motor Assessment Scale
Quality of Life : EQ-5D, SF-36, disease-specific scales
Adverse Events : Frequency and severity of complications
Secondary Endpoints
Neural Signal Quality : Signal-to-noise ratio, classification accuracy
Device Reliability : Uptime, maintenance requirements
User Satisfaction : System Usability Scale, device preference
Long-term Outcomes : 1-5 year follow-up measures
Regulatory Status
FDA Breakthrough Device Designations | Company | Device | Year | Indication | |---------|--------|------|------------| | Neuralink | N1 | 2020 | Paralysis | | Synchron | Stentrode | 2020 | Paralysis | | Paradromics | Connexus | 2023 | Communication | | Precision Neuroscience | Layer 7 | 2023 | Epilepsy |
CE Mark (European Union)
Synchron Stentrode: CE Marked (2022)
g.tec recovery: CE Marked (2021)
MindMaze: CE Marked (2020)
Leading Research Centers
United States
Stanford University : BrainGate consortium
University of Pittsburgh : Neural engineering lab
UCLA : Neural computation lab
Massachusetts General Hospital : Clinical trials
Europe
University of Tübingen : BCI research (Germany)
Charité Berlin : Neurotechnology (Germany)
University of Oxford : Neural interface research (UK)
Asia
Tokyo University : RIKEN BCI program (Japan)
Tsinghua University : Neural engineering (China)
Future Trial Directions
Anticipated Trials 2026-2028
Memory Prosthetic BCI : Trials for Alzheimer's-related memory impairment
Bidirectional Neural Interfaces : Reading and writing to neural tissue
Fully Implantable Systems : No external hardware requirements
Personalized Decoding : AI-based individual optimization
Emerging Indications
Huntington's Disease : Motor and cognitive symptom management
Multiple Sclerosis : Fatigue management and motor recovery
Traumatic Brain Injury : Cognitive rehabilitation
Chronic Pain : Neuromodulation for pain management
Cross-References
[Brain-Computer Interface Technologies](/technologies/bci-index) — Main BCI technology index
[Neuralink](/companies/neuralink) — Neuralink company profile
[Synchron](/companies/synchron) — Synchron company profile
[Parkinson's Disease Treatment](/therapeutics/parkinsons-disease-treatment) — PD treatment options
[ALS Therapeutics](/therapeutics/als-therapeutics) — ALS treatment options
[Stroke Rehabilitation](/therapeutics/stroke-rehabilitation) — Stroke recovery therapies
[Closed-Loop Neuromodulation](/technologies/closed-loop-neuromodulation) — Adaptive stimulation technology
See Also
[Alzheimer's Disease](/diseases/alzheimers-disease)
[Parkinson's Disease](/diseases/parkinsons-disease)
External Links
[PubMed](https://pubmed.ncbi.nlm.nih.gov/)
[KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
References
Unknown, ClinicalTrials.gov - Brain-Computer Interface Studies (n.d.)
Unknown, FDA Breakthrough Device Program (n.d.)
Pathway Diagram The following diagram shows the key molecular relationships involving BCI Clinical Trials for Neurodegenerative Diseases discovered through SciDEX knowledge graph analysis:
Mermaid diagram (expand to render)
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