Back to resultsNoninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Primary Purpose
Chronic Pain, Carpal Tunnel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Transcranial Ultrasound (TUS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring transcranial Direct Current Stimulation, Transcranial Ultrasound, Noninvasive brain stimulation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Spaulding Rehabilitation Network Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS + Active TUS
Sham tDCS + Sham TUS
Arm Description
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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 .
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
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.
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.
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.
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
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).
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
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.
Strength (grip and pinch)
Strength will be assessed using a grip dynamometer and a pinch dynamometer
Range of Motion (ROM)
The investigators will assess active and passive ROM in the elbow, forearm, wrist, thumb, digits
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.
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.
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.
Full Information
NCT ID
NCT04206215
First Posted
December 2, 2019
Last Updated
August 9, 2023
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04206215
Brief Title
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Official Title
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
October 6, 2024 (Anticipated)
Study Completion Date
January 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Carpal Tunnel Syndrome
Keywords
transcranial Direct Current Stimulation, Transcranial Ultrasound, Noninvasive brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS + Active TUS
Arm Type
Experimental
Arm Description
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Arm Title
Sham tDCS + Sham TUS
Arm Type
Sham Comparator
Arm Description
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
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
Intervention Name(s)
Transcranial Ultrasound (TUS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS)
Description
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.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Verbal Rating Scale (VRS)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Visual Analog Mood Scale (VAMS)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
tDCS Side Effects Questionnaire
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Multidimensional Pain Inventory (MPI)
Description
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 .
Time Frame
Measured for approximately for a total 9 weeks
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
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
Time Frame
Measured for approximately for a total 9 weeks
Title
Temporal Summation (TS)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Conditioned pain modulation (CPM)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Vibration Detection Threshold (VDT)
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Michigan Hand Outcomes Questionnaire (MHQ)
Description
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
Time Frame
Measured for approximately for a total 9 weeks
Title
Boston Carpal Tunnel Questionnaire
Description
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).
Time Frame
Measured for approximately for a total 9 weeks
Title
The Medical Outcomes Study 36-Item Short Form (SF-36)
Description
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
Time Frame
Measured for approximately for a total 9 weeks
Title
Electroencephalography (EEG)
Description
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.
Time Frame
Measured for approximately for a total 3 weeks
Title
Strength (grip and pinch)
Description
Strength will be assessed using a grip dynamometer and a pinch dynamometer
Time Frame
Measured for approximately for a total 9 weeks
Title
Range of Motion (ROM)
Description
The investigators will assess active and passive ROM in the elbow, forearm, wrist, thumb, digits
Time Frame
Measured for approximately for a total 9 weeks
Title
Thumb Reaching Test
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Reach to Pinch
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
Title
Wrist Flexion-Extension:
Description
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.
Time Frame
Measured for approximately for a total 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe Fregni, MD PhD mph
Phone
617-952-6156
Email
ffregni@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Whalen, BS
Phone
617-952-6158
Email
mwhalen7@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PhD MPH
Organizational Affiliation
Spaulding Rehabilitation Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Network Research Institute
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PhD MPH
Phone
617-952-6156
Email
ffregni@partners.org
First Name & Middle Initial & Last Name & Degree
Meghan Whalen, BS
Phone
617-952-6158
Email
mwhalen7@partners.org
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PhD MPH
12. IPD Sharing Statement
Learn more about this trial
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
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