An interventional study of Lower thoracic epidural spinal cord stimulation in Neurogenic Orthostatic Hypotension, sponsored by Aerospace Center Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Aerospace Center Hospital · Not applicable, Interventional, and Treatment
Neurogenic orthostatic hypotension is a disabling manifestation of synucleinopathies including Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. It commonly coexists with supine hypertension and requires individualized management. An implanted thoracic epidural stimulation system improved blood-pressure regulation, standing, and walking in a patient with multiple system atrophy, providing a rationale for further feasibility evaluation. This study evaluates the feasibility, safety, and preliminary hemodynamic response of lower thoracic epidural spinal cord stimulation in participants with symptomatic neurogenic orthostatic hypotension. All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety.
The study evaluates a commercially available 16-contact spinal cord stimulation electrode manufactured by PINS Medical, used with its compatible implanted stimulation system. The intended epidural target spans the T10 to T12 vertebral levels. This target is a study hypothesis informed by the rationale of spinal autonomic neuromodulation; it is not an established optimal target for neurogenic orthostatic hypotension. The device model, China registration certificate number, implantable pulse generator model, magnetic resonance imaging conditions, and permitted programming range will be documented before enrollment.
All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible stimulation system. After permanent implantation, follow-up occurs at 1 month, 3 months, 6 months, and 1 year to evaluate symptom improvement and safety.
Aerospace Center Hospital is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety.
Device: Lower thoracic epidural spinal cord stimulation
A 16-contact epidural spinal cord stimulation lead is placed with active contacts covering the intended T10 to T12 region. The lead is externalized for a trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is assessed using a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants meeting predefined response and safety criteria proceed to permanent implantation of the compatible spinal cord stimulation system. Initial programming uses individualized low-to-high titration within the device instructions for use: frequency 5 to 50 Hz and pulse width 200 to 500 μs. Amplitude increases from a subperception or lowest perceptible level until hemodynamic benefit, intolerable symptoms, or the device-specific permitted limit is reached.
Difference in lowest systolic blood pressure during standardized orthostatic challenge with stimulation ON versus OFF
During the externalized trial stimulation period, each participant completes standardized orthostatic challenges under randomized stimulation ON and OFF conditions. After at least 5 minutes of supine rest, blood pressure is measured continuously from the start of standing until 10 minutes of standing or until a prespecified stopping criterion is met. The lowest systolic blood pressure in each condition is identified. The outcome is the difference in lowest systolic blood pressure during stimulation ON versus OFF, calculated as ON minus OFF, in mmHg. A positive value indicates a higher lowest systolic blood pressure with stimulation ON. The ON and OFF order is randomized within each participant.
Time frame: During the externalized trial stimulation period, generally no more than 2 weeks after lead placement
Feasibility of the trial-to-implant pathway
Proportion of enrolled participants who complete the externalized trial stimulation period, meet predefined trial success criteria, receive permanent implantation of the spinal cord stimulation system, and complete scheduled follow-up assessments. Trial success is defined as at least one standardized orthostatic assessment during trial stimulation showing either an increase of at least 10 mmHg in the lowest systolic blood pressure with stimulation ON versus OFF, or an increase of at least 30% in orthostatic tolerance time, together with participant-reported overall symptom improvement and no device- or procedure-related serious adverse event.
Time frame: From enrollment through 12 months after permanent implantation
Orthostatic blood-pressure response
Change in systolic and diastolic blood pressure from supine baseline during standardized orthostatic challenge, time to lowest blood pressure, and occurrence of systolic blood pressure below 90 mmHg within 10 minutes of standing. Blood pressure is measured after at least 5 minutes of supine rest and continuously from standing onset until 10 minutes of standing or until a prespecified stopping criterion is met. A greater increase in blood pressure from supine baseline indicates better orthostatic blood-pressure response.
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic tolerance time
Duration of tolerated standing during the standardized orthostatic challenge, up to 10 minutes. The reason for early termination, including presyncope, syncope, intolerable symptoms, or safety concern, is recorded. A longer tolerated standing time indicates better orthostatic tolerance. Participants who complete 10 minutes of standing without early termination are assigned the maximum value of 10 minutes.
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic symptom burden
Change in score on a licensed or linguistically validated Chinese orthostatic hypotension symptom measure. The scale range and direction of possible scores will be provided once the instrument is confirmed. A decrease in score indicates improvement in orthostatic symptom burden if the selected instrument uses a higher score to indicate worse symptoms.
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Patient Global Impression of Change
Participant-rated global change in orthostatic symptoms. Participants rate their overall change in orthostatic symptoms compared with baseline using a validated Patient Global Impression of Change scale. The scale typically ranges from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse, or according to the validated version used.
Time frame: Externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Supine hypertension and ambulatory blood pressure
Supine blood pressure after 5 minutes of rest and prespecified metrics from 24-hour ambulatory blood-pressure monitoring, including nighttime blood pressure where available.Metrics may include mean 24-hour, daytime, and nighttime systolic and diastolic blood pressure, as well as the proportion of participants with supine systolic blood pressure at least 180 mmHg or diastolic blood pressure at least 110 mmHg. A lower supine blood pressure indicates less severe supine hypertension.
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Device-, procedure-, and stimulation-related adverse events
Number and proportion of participants with adverse events and serious adverse events, classified by severity, relationship to device or procedure, action taken, and outcome. Events are assessed from consent through 12 months after permanent implantation and are coded according to the applicable regulatory and institutional standards.
Time frame: From consent through 12 months after permanent implantation
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Aerospace Center Hospital