Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

NCT ID: NCT04206215

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2026-01-05

Brief Summary

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

Conditions

Chronic Pain; Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS + Active TUS

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.

Transcranial Ultrasound (TUS)

Intervention Type: DEVICE

Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Sham tDCS + Sham TUS

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Group Type: SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.

Transcranial Ultrasound (TUS)

Intervention Type: DEVICE

Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Interventions

transcranial Direct Current Stimulation (tDCS)

Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.

Intervention Type: DEVICE

Transcranial Ultrasound (TUS)

Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to provide informed consent to participate in the study

2. Subjects between 18 to 80 years old

3. Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 3 on a 0-10 VAS scale).

4. Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)

5. Must have the ability to feel pain as self-reported.

Exclusion Criteria

1. Subject is pregnant

2. Contraindications to tDCS+TUS:

1. intracranial metal implant

2. implanted brain medical devices

3. History of alcohol or drug abuse within the past 6 months as self-reported

4. Use of carbamazepine within the past 6 months as self-reported

5. Suffering from major depression (with a PHQ-9 score of ≥20)

6. History of neurological disorders involving stroke, brain tumors, or epilepsy with residual neurological symptoms as self-reported (note patients will also be evaluated via EEG at baseline about 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))

7. History of unexplained fainting spells as self-reported

8. History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits

9. History of intracranial neurosurgery as self-reported

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Highland Instruments, Inc.

INDUSTRY

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Network

Locations

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Felipe Fregni, MD PhD mph

Role: CONTACT

ffregni@partners.org

617-952-6156

Meghan Whalen, BS

Role: CONTACT

mwhalen7@partners.org

617-952-6158

Facility Contacts

Felipe Fregni, MD PhD MPH

Role: primary

ffregni@partners.org

617-952-6156

Meghan Whalen, BS

Role: backup

mwhalen7@partners.org

617-952-6158

Other Identifiers

2019P002804

Identifier Type: -

Identifier Source: org_study_id