Chronic PainNCT04206215
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
A study testing transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) in people with Chronic Pain and Carpal Tunnel Syndrome, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Carpal Tunnel Syndrome
- What is being tested?
- transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 28 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent to participate in the study
- Subjects between 18 to 80 years old
- 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).
- Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
- Must have the ability to feel pain as self-reported.
Who cannot join
- Subject is pregnant
- Contraindications to tDCS+TUS:
- intracranial metal implant
- implanted brain medical devices
- History of alcohol or drug abuse within the past 6 months as self-reported
- Use of carbamazepine within the past 6 months as self-reported
Show all 11Show fewer
- Suffering from major depression (with a PHQ-9 score of ≥20)
- 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))
- History of unexplained fainting spells as self-reported
- History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
- History of intracranial neurosurgery as self-reported
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, 02129
Felipe Fregni, MD PhD MPH, 617-952-6156, ffregni@partners.org
Meghan Whalen, BS, 617-952-6158, mwhalen7@partners.org
About this study
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
- Being tested
- transcranial Direct Current Stimulation (tDCS), Transcranial Ultrasound (TUS)
- Keywords
- transcranial Direct Current Stimulation, Transcranial Ultrasound, Noninvasive brain stimulation
- Medical subject headings
- Chronic Pain, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)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)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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Active TUS | Experimental | Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Transcranial Ultrasound (TUS) |
| Sham tDCS + Sham TUS | Sham comparator | Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Transcranial Ultrasound (TUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score (VAS)
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome.
The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain.
Measured: 9 weeks
Secondary outcomes (19)
Verbal Rating Scale (VRS)
Changes in the Verbal Rating Scale (VRS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VRS minimum value is no pain and the maximum value is severe pain. Being severe pain the worst outcome.
Measured: Measured for approximately for a total 9 weeks
Visual Analog Mood Scale (VAMS)
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale.
This scale will range from zero (low or worst mood) to 10 on anxiety, depression, sleepiness and stress.
Measured: Measured for approximately for a total 9 weeks
Montreal Cognitive Assessment (MOCA)
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the MOCA. MOCA scores range between 0 and 30, a score of 26 and higher generally considered normal.
Measured: Measured for approximately for a total 9 weeks
tDCS Side Effects Questionnaire
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 4-point scale, where 1 is absent and 4 is severe. The scale will also be administered at the follow-ups.
Measured: Measured for approximately for a total 9 weeks
Patient Health Questionnaire (PHQ-9)
The investigators will measure safety of tDCS and TUS by measuring changes of mood through the PHQ-9. The scoring goes from 0 to 27, where 0 is no depression and 27 is severe depression.
Measured: Measured for approximately for a total 9 weeks
Multidimensional Pain Inventory (MPI)
The investigators will monitor the impact of pain with the MPI of tDCS and TUS. It consist in 3 sections (Pain Impact , responses by significant others, activities and each item is rated on a 7-point scale (0-6), where higher scores represent severe symptoms .
Measured: Measured for approximately for a total 9 weeks
Neuropathic Pain Symptom Inventory (NPSI)
The investigators will monitor the changes of neuropathic pain in subjects going through the study before and after tDCS and TUS. It include 12 items in total, this tool evaluates mean pain intensity in the last 24 hours in a numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors
Measured: Measured for approximately for a total 9 weeks
Temporal Summation (TS)
The investigators will monitor the changes of temporal summation in the study before and after tDCS and TUS. This will be assessed by Von Frey filaments. This is assessed by having the participant rate their pain after a single stimulus (6.65, 300 g) applied for 0.5 s and then again after a series of 10 (6.65, 300 g) stimuli are applied at 1-s intervals.
Measured: Measured for approximately for a total 9 weeks
Conditioned pain modulation (CPM)
Changes in the conditioned pain modulation will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in changing the conditioned pain modulation system in subjects with Carpal Tunnel Syndrome. This will be assessed by applying pressure with an algometer.
Measured: Measured for approximately for a total 9 weeks
Vibration Detection Threshold (VDT)
Changes in the vibration detection threshold will be measured , this is performed with a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale) placed on the skin surface and is determined by asking the participant to tell the examiner when the vibration is no longer felt.
Measured: Measured for approximately for a total 9 weeks
Michigan Hand Outcomes Questionnaire (MHQ)
This a hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist. The MHQ contains six distinct scales: overall hand function, activities of daily living , pain, work performance, aesthetics, and patient satisfaction with hand function. They are scored from 0 - 100 in which 100 is the best possible ability
Measured: Measured for approximately for a total 9 weeks
Boston Carpal Tunnel Questionnaire
This is an instrument specifically designed for Carpal Tunnel Syndrome (CTS) and validated for CTS therapy assessments (consisting of the Functional Status Scale and Symptom Severity Scale scores. The symptom severity scale has 11 questions scored from 1 point (mildest) to 5 points (most severe).
Measured: Measured for approximately for a total 9 weeks
The Medical Outcomes Study 36-Item Short Form (SF-36)
This a generic health status instrument that measures 8-health related concepts using 36 questions and provides a profile of functional health and well-being scores. It also provides a psychometrical index of physical and mental health. Each scale is transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability
Measured: Measured for approximately for a total 9 weeks
Electroencephalography (EEG)
Investigators will measure electroencephalogram activity to monitor safety. Baseline recordings will be reviewed to ensure that there are no potential electroencephalographic safety criteria prior to stimulation. This qualitative analysis will focus on pathological EEG activity such as epileptiform discharges or persistent focal slowing.
Measured: Measured for approximately for a total 3 weeks
Strength (grip and pinch)
Strength will be assessed using a grip dynamometer and a pinch dynamometer
Measured: Measured for approximately for a total 9 weeks
Range of Motion (ROM)
The investigators will assess active and passive ROM in the elbow, forearm, wrist, thumb, digits
Measured: Measured for approximately for a total 9 weeks
Thumb Reaching Test
Subject will be asked to reach the base of the little finger with their thumb. The task will be repeated up to 10 times. Primary data will be taken from inertial sensors placed on the thumb and little finger.
Measured: Measured for approximately for a total 9 weeks
Reach to Pinch
Subject will be asked to perform a reach to pinch task . The task will be repeated up to 10 times. Primary data will be taken from camera and accelerometers/gyroscopes placed on the thumb and index finger.
Measured: Measured for approximately for a total 9 weeks
Wrist Flexion-Extension:
Subject will be asked to flex-extend their wrist up to 10 times. Primary data will be taken from an accelerometer/gyroscope placed on the wrist and the camera.
Measured: Measured for approximately for a total 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start16 Apr 2021
- Primary completion2 Jul 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Highland Instruments, Inc.
- Responsible party
- Principal investigator, Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD PhD MPH, Principal investigator, Spaulding Rehabilitation Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206215
- Sponsor's protocol ID
- 2019P002804
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2019
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04206215
- Acronym / sponsor ID
- 2019P002804
- Conditions
- Chronic Pain, Carpal Tunnel Syndrome
- Keywords
- transcranial Direct Current Stimulation, Transcranial Ultrasound, Noninvasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Highland Instruments, Inc.
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Active TUS | Experimental | Device: transcranial Direct Current Stimulation (tDCS), Device: Transcranial Ultrasound (TUS)Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). |
| Sham tDCS + Sham TUS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS), Device: Transcranial Ultrasound (TUS)Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent to participate in the study
- Subjects between 18 to 80 years old
- 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).
- Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
- Must have the ability to feel pain as self-reported.
Key exclusion criteria (11 listed)
- Subject is pregnant
- Contraindications to tDCS+TUS:
- History of alcohol or drug abuse within the past 6 months as self-reported
- Use of carbamazepine within the past 6 months as self-reported
- Suffering from major depression (with a PHQ-9 score of ≥20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active tDCS + Active TUS, Sham tDCS + Sham TUS |
| 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. | Device | Active tDCS + Active TUS, Sham tDCS + Sham TUS |
Primary outcome
Visual Analogue Score (VAS)
Time frame: 9 weeks
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain.
19 secondary outcomes
Verbal Rating Scale (VRS)
Time frame: Measured for approximately for a total 9 weeks
Visual Analog Mood Scale (VAMS)
Time frame: Measured for approximately for a total 9 weeks
Montreal Cognitive Assessment (MOCA)
Time frame: Measured for approximately for a total 9 weeks
tDCS Side Effects Questionnaire
Time frame: Measured for approximately for a total 9 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: Measured for approximately for a total 9 weeks
Multidimensional Pain Inventory (MPI)
Time frame: Measured for approximately for a total 9 weeks
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Measured for approximately for a total 9 weeks
Temporal Summation (TS)
Time frame: Measured for approximately for a total 9 weeks
Conditioned pain modulation (CPM)
Time frame: Measured for approximately for a total 9 weeks
Vibration Detection Threshold (VDT)
Time frame: Measured for approximately for a total 9 weeks
Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: Measured for approximately for a total 9 weeks
Boston Carpal Tunnel Questionnaire
Time frame: Measured for approximately for a total 9 weeks
The Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame: Measured for approximately for a total 9 weeks
Electroencephalography (EEG)
Time frame: Measured for approximately for a total 3 weeks
Strength (grip and pinch)
Time frame: Measured for approximately for a total 9 weeks
Range of Motion (ROM)
Time frame: Measured for approximately for a total 9 weeks
Thumb Reaching Test
Time frame: Measured for approximately for a total 9 weeks
Reach to Pinch
Time frame: Measured for approximately for a total 9 weeks
Wrist Flexion-Extension:
Time frame: Measured for approximately for a total 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felipe Fregni, MD PhD MPH principal investigator
Spaulding Rehabilitation Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) in people with Chronic Pain and Carpal Tunnel Syndrome, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Fregni, MD PhD mph (617-952-6156, ffregni@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.