Clinical trial NCT04206215: Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Official title: Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Carpal Tunnel Syndrome
Keywords: transcranial Direct Current Stimulation
Transcranial Ultrasound
Noninvasive brain stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2019-12-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: 9 weeks
Secondary outcomes:
measure: Verbal Rating Scale (VRS)
timeFrame: Measured for approximately for a total 9 weeks
measure: Visual Analog Mood Scale (VAMS)
timeFrame: Measured for approximately for a total 9 weeks
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Measured for approximately for a total 9 weeks
measure: tDCS Side Effects Questionnaire
timeFrame: Measured for approximately for a total 9 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured for approximately for a total 9 weeks
measure: Multidimensional Pain Inventory (MPI)
timeFrame: Measured for approximately for a total 9 weeks
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Measured for approximately for a total 9 weeks
measure: Temporal Summation (TS)
timeFrame: Measured for approximately for a total 9 weeks
measure: Conditioned pain modulation (CPM)
timeFrame: Measured for approximately for a total 9 weeks
measure: Vibration Detection Threshold (VDT)
timeFrame: Measured for approximately for a total 9 weeks
measure: Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: Measured for approximately for a total 9 weeks
measure: Boston Carpal Tunnel Questionnaire
timeFrame: Measured for approximately for a total 9 weeks
measure: The Medical Outcomes Study 36-Item Short Form (SF-36)
timeFrame: Measured for approximately for a total 9 weeks
measure: Electroencephalography (EEG)
timeFrame: Measured for approximately for a total 3 weeks
measure: Strength (grip and pinch)
timeFrame: Measured for approximately for a total 9 weeks
measure: Range of Motion (ROM)
timeFrame: Measured for approximately for a total 9 weeks
measure: Thumb Reaching Test
timeFrame: Measured for approximately for a total 9 weeks
measure: Reach to Pinch
timeFrame: Measured for approximately for a total 9 weeks
measure: Wrist Flexion-Extension:
timeFrame: Measured for approximately for a total 9 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Network
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: