BCI Clinical Trials for Neurodegenerative Diseases

BCI Clinical Trials Neurodegenerative

Overview

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

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

Common Exclusion Criteria

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

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

Pathway Diagram

The following diagram shows the key molecular relationships involving BCI Clinical Trials for Neurodegenerative Diseases discovered through SciDEX knowledge graph analysis: