## Protocol Section
### Identification Module
**NCT ID:** NCT06437548

**Brief Title:** Epidural Stimulation for Upper Extremity Function

**Official Title:** Spinal Cord Stimulation for Reanimation After Nervous System Injury

#### Organization Study ID Info
**ID:** 2024P000185
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2027-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Responsible Party

**Investigator Affiliation:** Brigham and Women's Hospital

**Investigator Full Name:** Yi Lu, MD PhD

**Investigator Title:** Director of Neurosurgical Trauma, Associate Professor of Neurosurgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.

At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.

The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.

**Detailed Description:** The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.

At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.

Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.

Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.

Temporary leads will be removed after approximately 4 weeks.

At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed.

### Conditions Module

**Conditions:**

- Spinal Cord Injury Cervical

- Tetraplegia

**Keywords:**

- spinal

- cord

- stimulation

- percutaneous

- peripheral

- nerve

- transfer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Percutaneous temporary spinal cord stimulator. Parameters for upper extremity motor function will be assessed with the stimulation turned on and off. Muscle strength and force will be assessed with the stim turned on and off.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants will undergo baseline muscle strength and force assessments. Participants will also answer questionnaires on pain and quality of life. An optional nerve health assessment with needle electromyography and neuroimaging may be performed.

Participants will undergo clinically indicated percutaneous (temporal) cervical epidural leads placement.

Weeks 0-4 post-leads placement: during weekly visits upper extremity muscle strength and force will be assessed, pain and quality of life questionnaires will be completed (1 research visit per week)

At approximately 28 days temporary leads will be removed.

At the last visit, muscle strength and force in upper extremity muscle groups will be assessed, participants will complete pain and quality of life questionnaires. Participants may choose to undergo an optional nerve health assessment with needle electromyography and neuroimaging.

**Intervention Names:**

- Device: Percutaneous spinal cord stimulation

**Label:** Percutaneous spinal cord stimulation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Percutaneous spinal cord stimulation

**Description:** The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.

**Name:** Percutaneous spinal cord stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome.

**Measure:** Nerve transfer recipient muscle strength

**Time Frame:** 0-6 weeks

#### Secondary Outcomes

**Description:** Change in muscle force generated by recipient nerve transfer muscle group with spinal cord stimulation activated. Muscle force is measured with a hand-held dynamometer. This is measured in Newtons, with a larger number meaning greater force and a better outcome.

**Measure:** Nerve transfer recipient muscle force

**Time Frame:** 0-6 weeks

**Description:** Change in neck and upper extremity pain measured with the Numeric Rating Scale (NRS). NRS scale ranges from 0 (No pain) to 10 (worst possible pain), with a lower number representing a better outcome. A positive change in NRS from baseline to follow-up visits suggests improvement of pain.

**Measure:** Neck and upper extremity pain

**Time Frame:** 0-6 weeks

**Description:** Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes.

**Measure:** Amplitude of percutaneous stimulation

**Time Frame:** 0-4 weeks

**Description:** Optimized frequency of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Frequency is measured in Hz (Hertz).

**Measure:** Frequency of percutaneous stimulation

**Time Frame:** 0-4 weeks

**Description:** Optimized pulse width of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Pulse width is measured in microseconds.

**Measure:** Pulse width of percutaneous stimulation

**Time Frame:** 0-4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years and ≤65
* Provides informed consent
* History of upper extremity nerve transfer \> 6 months prior to enrollment
* Completion of standard post-nerve transfer occupational therapy
* Baseline upper extremity strength of \< 5/5 grade with the MRC
* Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
* Willing and able to adhere to the study protocol

Exclusion Criteria:

* Central nervous system (CNS) malignancy
* A contraindication to the SCS procedure
* Diagnosis that precludes the patient from full participation in the protocol
* A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
* Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment
* For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
* Other factors that prevent participation in the opinion of the surgeon-principal investigator

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bjohnston2@mgb.org

**Name:** Benjamin R. Johnston, MD PhD

**Phone:** (617) 525-7378

**Role:** CONTACT

**Contact 2:**

**Email:** jchalif@bwh.harvard.edu

**Name:** Joshua I. Chalif, MD PhD

**Phone:** (617) 525-7378

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Brigham and Women's Hospital

**Name:** Yi Lu, MD PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** Individual participant data will not be shared with researchers outside of the study, except as required de-identified data for publication purposes.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Bertelli JA, Ghizoni MF. Nerve transfers for restoration of finger flexion in patients with tetraplegia. J Neurosurg Spine. 2017 Jan;26(1):55-61. doi: 10.3171/2016.5.SPINE151544. Epub 2016 Aug 5.

**PMID:** 27494781

**Citation:** Fox IK. Nerve Transfers in Tetraplegia. Hand Clin. 2016 May;32(2):227-42. doi: 10.1016/j.hcl.2015.12.013. Epub 2016 Mar 10.

**PMID:** 27094894

**Citation:** Lu DC, Edgerton VR, Modaber M, AuYong N, Morikawa E, Zdunowski S, Sarino ME, Sarrafzadeh M, Nuwer MR, Roy RR, Gerasimenko Y. Engaging Cervical Spinal Cord Networks to Reenable Volitional Control of Hand Function in Tetraplegic Patients. Neurorehabil Neural Repair. 2016 Nov;30(10):951-962. doi: 10.1177/1545968316644344. Epub 2016 May 18.

**PMID:** 27198185

**Citation:** Barra B, Conti S, Perich MG, Zhuang K, Schiavone G, Fallegger F, Galan K, James ND, Barraud Q, Delacombaz M, Kaeser M, Rouiller EM, Milekovic T, Lacour S, Bloch J, Courtine G, Capogrosso M. Epidural electrical stimulation of the cervical dorsal roots restores voluntary upper limb control in paralyzed monkeys. Nat Neurosci. 2022 Jul;25(7):924-934. doi: 10.1038/s41593-022-01106-5. Epub 2022 Jun 30.

**PMID:** 35773543

**Citation:** Greiner N, Barra B, Schiavone G, Lorach H, James N, Conti S, Kaeser M, Fallegger F, Borgognon S, Lacour S, Bloch J, Courtine G, Capogrosso M. Recruitment of upper-limb motoneurons with epidural electrical stimulation of the cervical spinal cord. Nat Commun. 2021 Jan 19;12(1):435. doi: 10.1038/s41467-020-20703-1.

**PMID:** 33469022

**Citation:** Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.

**PMID:** 36807682

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000010243

- Term: Paralysis

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M14632

- Name: Quadriplegia

- Relevance: HIGH

- As Found: Tetraplegia

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000011782

- Term: Quadriplegia

### Misc Info Module

- Version Holder: 2024-05-31
