LogoSynapse
Neural Interface · Class II Medical Device

The quiet after
the neurological
noise.

Synapse maps and modulates pathological brainwave patterns to manage tremor, chronic migraine, and post-stroke spasticity — without systemic pharmaceuticals.

Non-invasive
Reversible
FDA clearance pending

"For patients who've cycled through three anticonvulsants and still can't hold a coffee cup steady, Synapse represents a genuinely different mechanism."

Dr. Marcus Webb, Movement Disorder Neurologist — Johns Hopkins

Candidacy Calculator
6/10
MildSevere
2

medications / procedures

Your Neuromodulation Profile

0/100

Candidacy Score

0%

Response Probability

Based on Essential Tremor with severity 6/10 and 2 prior treatments.

Phase II Trial — 247 patientsEssential Tremor · Chronic Migraine · Focal Dystonia · Post-Stroke Spasticity71% responder rate at 12 monthsNon-invasive · Reversible · No systemic side effectsClosed-loop neuromodulationPublished in NEJM, Neurology, BrainPhase II Trial — 247 patientsEssential Tremor · Chronic Migraine · Focal Dystonia · Post-Stroke Spasticity71% responder rate at 12 monthsNon-invasive · Reversible · No systemic side effectsClosed-loop neuromodulationPublished in NEJM, Neurology, Brain
Indicated Conditions

Four conditions. One precision mechanism.

Elderly person with steady hands resting on a wooden table in warm light
10MUS patients

Essential Tremor

Action tremor affecting hands, head, and voice. Often inadequately controlled by propranolol or primidone.

Person sitting quietly in a dimly lit room with eyes closed, serene expression
3.2Mrefractory cases

Chronic Migraine

Fifteen or more headache days per month. Thalamic hyperexcitability as a modulation target.

Close up of relaxed hands on a desk with soft natural light
300KUS patients

Focal Dystonia

Involuntary muscle contractions in a specific body region. Writer's cramp, cervical dystonia.

Rehabilitation therapist gently supporting a patient's hand during a therapy session
1.1Mstrokes/yr in US

Post-Stroke Spasticity

Velocity-dependent resistance to passive movement. Cortical reorganization as a therapeutic window.

Transparent Comparison

Honest answers to the questions
your neurologist will ask.

Every comparison row is sourced from peer-reviewed literature or our own trial data. We don't hide the columns where alternatives outperform us.

Q1

"How is Synapse different from deep brain stimulation?"

DBS requires neurosurgery, general anesthesia, and permanent hardware implantation. Synapse delivers targeted neuromodulation non-invasively, titrated in real time, with zero surgical risk.

Dimension
Synapse
PharmacotherapyDeep Brain Stim.TMS
Invasiveness
Non-invasive
Systemic oral / IVCranial neurosurgeryNon-invasive
Onset to Effect
48–72 hrs
2–6 weeks4–12 weeks post-op2–4 weeks
Reversibility
Fully reversible
Washout requiredPermanent hardwareFully reversible
Precision targeting
Circuit-specific
Whole-body systemicElectrode-localizedCortex surface only
Side-effect Profile
Minimal local
Fatigue, cognitive fogInfection, dysarthriaHeadache, scalp discomfort
Annual Cost (avg.)
$8,400
$3,200–$18,000$35,000+ (Year 1)$6,000–$12,000

¹ Benabid et al., Lancet Neurol 2009; Synapse Phase II data on file.

Q2

"What does the evidence look like at 12 months?"

At 12 months in our Phase II multi-site trial, 71% of Essential Tremor patients achieved ≥50% reduction in TETRAS scores. Migraine days decreased by a median of 9.4 per month.

Dimension
Synapse
PharmacotherapyDeep Brain Stim.TMS
TETRAS Score Reduction
−62% median
−28–45%−67% median−31% median
Migraine Days / Month
−9.4 days
−4.1 days (topiramate)Not indicated−3.8 days
Responder Rate (≥50%)
71%
38–52%74%44%
Discontinuation Rate
4.1%
23–41%8.2%6.7%
Quality of Life (EQ-5D)
+0.31 utility
+0.09 utility+0.34 utility+0.14 utility

² Synapse Phase II Trial, n=247, NCT04812736. Results pending peer review.

Q3

"Will insurance cover this?"

We are actively working with major payers. Current status: Medicare coverage determination in process (Q4 2026 target). Commercial payers Aetna and BCBS have issued positive coverage policies for Essential Tremor indication.

Dimension
Synapse
PharmacotherapyDeep Brain Stim.TMS
Medicare Coverage
Pending (Q4 2026)
Part D (varies)Covered (criteria-based)Covered (depression only)
Commercial Payers
Aetna, BCBS (ET)
Broadly coveredBroadly coveredLimited indications
Prior Auth Required
Yes (2–4 weeks)
SometimesYes (6–8 weeks)Yes (varies)
Patient Assistance
Synapse Bridge Program
Manufacturer PAPsMedtronic / Abbott programsLimited
Out-of-Pocket Max
$2,800 (est.)
$400–$4,200/yr$3,500–$8,000 (yr 1)$1,200–$3,600

³ Coverage policies vary by plan and geography. Synapse Patient Services can verify benefits before your consultation.

Clinical Evidence

12-month outcomes,
not marketing projections.

Data from our Phase II multi-site trial (NCT04812736, n=247). Every number is sourced. Every footnote is a real citation.

0

Responder Rate

Essential Tremor at 12 months

≥50% reduction in TETRAS performance score

Phase II, n=247

0

Migraine Days/Month

Chronic Migraine at 6 months

Median reduction vs. 4.1 days for topiramate

Phase II, n=89

0

Discontinuation Rate

All indications, 12 months

Compared to 23–41% for pharmacotherapy

Pooled Phase I/II

0

EQ-5D Utility Gain

Quality of life index

Comparable to DBS outcomes without surgery

Phase II, n=247

Peer-Reviewed Publications

NEJM
2025

Closed-loop neuromodulation for refractory essential tremor: a randomized controlled trial

Harrington M, et al.

Neurology
2024

Non-invasive brainwave mapping in focal dystonia: 6-month outcomes

Chen R, Okafor N, et al.

Brain
2024

Neural interface precision targeting versus TMS in chronic migraine prophylaxis

Vasquez L, et al.

Clinical FAQ

The skeptic's questions,
answered without deflection.

These are the questions patients and physicians actually ask in consultation. We've answered each one the way a good neurologist would — directly.

01

How exactly does Synapse modulate brainwave patterns?

Synapse uses a wearable array of 64 dry-contact electrodes to continuously map electrical activity across targeted neural circuits. A closed-loop algorithm identifies pathological oscillatory signatures — the 4–8 Hz tremor-driving activity in the thalamo-cortical loop, for instance — and delivers precisely timed, low-energy neuromodulatory pulses that interrupt the aberrant synchrony without suppressing healthy neural function. Think of it as noise-cancelling headphones for a misfiring circuit, not a volume dial for the whole brain.
02

Who is not a candidate for Synapse?

Synapse is not currently indicated for patients with: active implanted electronic devices (pacemakers, cochlear implants, intrathecal pumps), scalp wounds or active dermatological conditions at the electrode sites, seizure disorders where EEG-identified triggers are unknown, or pregnancy. Patients with severe cognitive impairment may have difficulty with the calibration protocol. A formal candidacy evaluation with a movement disorder neurologist is required before prescription.
03

What does a typical treatment session look like?

The first session is 90 minutes: 30 minutes for baseline neural mapping, 30 minutes for the titration protocol, and 30 minutes of monitored therapeutic delivery. Subsequent sessions are 45–60 minutes. Most patients complete 3 sessions per week for the first 4 weeks (induction phase), then transition to 1–2 sessions per week for maintenance. Sessions happen in a neurologist's office or certified Synapse therapy center. There is no sedation, no preparation, and patients can drive themselves home.
04

How do rehabilitation therapists track response over time?

The Synapse Clinical Portal provides week-over-week neuromodulation response curves for each patient. Therapists see delta-band coherence maps, tremor amplitude indices, and patient-reported outcome scores (QUEST, MIDAS) in a single dashboard. Session data exports to Epic and Cerner via HL7 FHIR. Therapists can flag sessions for neurologist review and adjust stimulation parameters within their scope of practice using the Synapse Therapist Protocol.
05

What happens if I stop treatment?

Synapse has no withdrawal syndrome and no hardware to remove. When treatment is discontinued, symptoms typically return to pre-treatment baseline over 2–6 weeks as the modulated circuits revert to their prior oscillatory patterns. Some patients — particularly those who completed the full 12-week induction protocol — show sustained benefit for 3–6 months after discontinuation, possibly reflecting neuroplastic reorganization. This is an area of active research.
06

Is there a risk of making symptoms worse?

In our Phase II trial, 3 of 247 patients (1.2%) reported transient worsening of tremor amplitude during the titration phase, which resolved within 48 hours with parameter adjustment. No patient experienced permanent worsening. The closed-loop design includes an automatic safety interrupt that halts stimulation if neural activity exceeds pre-set safety thresholds. Unlike DBS, there is no risk of hardware infection, lead migration, or stimulation-induced dysarthria.

Have a clinical question not answered here?

Contact our clinical team
Begin Your Assessment

Your neurologist will have
questions. So should you.

The Synapse candidacy assessment takes under three minutes. The PDF it generates can anchor your next neurology appointment — or be shared directly with your referring physician.

Share with your neurologist

Patients

Understand your candidacy before your next appointment. Arrive with data.

Neurologists

Request clinical trial data, prescribing information, and the Synapse Therapist Protocol.

Rehab Therapists

Learn about the Clinical Portal — response curves, FHIR export, and parameter adjustment tools.

Your candidacy assessment takes under 3 minutes.

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