Recruiting NCT04206215
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial Direct Current Stimulation (tDCS), Transcranial Ultrasound (TUS).
- Who it may be relevant to
- Registry conditions: Chronic Pain, Carpal Tunnel Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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 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.
Primary outcome measures
- Visual Analogue Score (VAS) [Time frame: 9 weeks]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Spaulding Rehabilitation Network Research Institute — Charlestown
Identifiers
NCT: NCT04206215 · 2019P002804