Noninvasive Brain Stimulation for Carpal Tunnel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Felipe Fregni, MD, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Carbamazepine

Disqualifiers: Pregnancy, Major depression, Neurological disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used carbamazepine in the past 6 months.

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for Carpal Tunnel Syndrome?

Research shows that transcranial direct current stimulation (tDCS) can help improve hand motor skills in stroke patients, suggesting it might also be beneficial for conditions like Carpal Tunnel Syndrome that affect hand function. ^{1 2 3 4 5}

Is noninvasive brain stimulation safe for humans?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe for humans, with no severe complications reported at intensities of 4 mA or less for up to 60 minutes per day. Studies show that the amount of electricity used is much lower than levels that could cause permanent brain changes, and adverse effects are usually mild and temporary. ^{6 7 8 9 10}

How is the treatment of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) unique for carpal tunnel syndrome?

This treatment is unique because it uses noninvasive brain stimulation techniques, which are different from traditional methods like surgery or acupuncture. Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) aim to modulate brain activity to alleviate symptoms, offering a novel approach compared to other treatments that focus directly on the wrist or nerve. ^{11 12 13 14 15}

Research Team

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Spaulding Rehabilitation Network

Eligibility Criteria

This trial is for adults aged 18-80 with Carpal Tunnel Syndrome causing chronic pain despite previous treatments. Participants must have had pain for at least 6 months, feel it on most days, and rate it at least a 3 out of 10. They can't join if they're pregnant, have used certain medications recently, suffer from major depression or neurological issues like stroke or epilepsy, have metal implants in the brain, or a history of substance abuse.

Inclusion Criteria

Able to provide informed consent to participate in the study

I am between 18 and 80 years old.

I have chronic wrist pain from CTS, spreading beyond the usual areas, for over 6 months.

Exclusion Criteria

I have not taken carbamazepine in the last 6 months.

Subject is pregnant

I do not have any metal implants in my head.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 minutes of active or sham transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) for the treatment of pain in Carpal Tunnel Syndrome

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Direct Current Stimulation (tDCS) (Behavioural Intervention)
• Transcranial Ultrasound (TUS) (Behavioural Intervention)

Trial Overview The study tests whether transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) can reduce pain in Carpal Tunnel Syndrome patients better than sham (fake) stimulation. The hypothesis is that active stimulation will lower pain levels more effectively.

Participant Groups

Group I: Active tDCS + Active TUS Experimental Treatment 2 Interventions

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

Group II: Sham tDCS + Sham TUS Placebo Group 2 Interventions

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

Transcranial Direct Current Stimulation (tDCS) is already approved in Canada for the following indications:

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Spaulding Rehabilitation Network Research Institute Charlestown, MA

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Patients Recruited

11,200+

Highland Instruments, Inc.

Industry Sponsor

Trials

11

Patients Recruited

650+

Findings from Research

In a study of 26 chronic stroke patients, combining anodal transcranial direct current stimulation (tDCS) with occupational therapy significantly improved fine motor skills, as measured by the modified Jebsen-Taylor Hand Function Test, compared to a sham stimulation group.

The benefits of the tDCS intervention were evident immediately after treatment and persisted up to 40 days later, although there was no observed impact on handgrip strength or upper limb function scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of anodal tDCS and occupational therapy on fine motor skill deficits in patients with chronic stroke. Ilić, NV., Dubljanin-Raspopović, E., Nedeljković, U., et al.[2018]

Optimized high-definition montages for transcranial direct current stimulation (tDCS) can increase stimulation intensity by an average of 0.3 V/m compared to unoptimized montages, which is crucial for targeting areas beneath skull defects.

Large skull defects with titanium or acrylic plates can reduce stimulation intensity by about 80%, while smaller defects filled with cerebrospinal fluid or scar tissue can increase stimulation intensity by about 200%, highlighting the importance of individual anatomical considerations in tDCS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. Guillen, A., Truong, DQ., Datta, A., et al.[2023]

In a study of 32 stroke inpatients, those who received bihemispheric transcranial direct current stimulation (tDCS) alongside physical and occupational therapy showed significantly greater improvements in upper extremity motor function compared to those who received sham tDCS.

The most notable benefits were observed in chronic stroke patients (over 6 months post-stroke), indicating that tDCS may be particularly effective for this group in enhancing their functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. Alisar, DC., Ozen, S., Sozay, S.[2020]

A systematic review of 12 studies involving 869 participants found that acupuncture and laser acupuncture may have little to no significant effect on the symptoms of carpal tunnel syndrome (CTS) compared to placebo or sham treatments, indicating uncertainty about their efficacy.

While acupuncture was associated with minimal adverse events, such as local pain and bruising, no serious adverse events were reported, suggesting it is a relatively safe option, though high-quality trials are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. Choi, GH., Wieland, LS., Lee, H., et al.[2022]

Intramuscular stimulation (IMS) of the pronator teres muscle significantly improved clinical parameters in patients with carpal tunnel syndrome (CTS), showing better results than the control group receiving acupuncture.

Both IMS and acupuncture groups experienced a reduction in the diameter of the median nerve, but IMS demonstrated greater overall clinical improvement, suggesting it may be a low-risk alternative treatment while awaiting surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. Kvist, KB., Hilland, R., Enehaug, R., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of anodal tDCS and occupational therapy on fine motor skill deficits in patients with chronic stroke. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of different noninvasive brain stimulation therapies for recovery of global cognitive function, attention, memory, and executive function after stroke: a network meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome: clinical outcome after low-level laser acupuncture, microamps transcutaneous electrical nerve stimulation, and other alternative therapies--an open protocol study. [2004]

12. South Africa pubmed.ncbi.nlm.nih.gov

The effectiveness of the median nerve neurodynamic mobilisation techniques in women with mild or moderate bilateral carpal tunnel syndrome: A single-blind clinical randomised trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Ultrasound therapy adds no benefit to splinting in carpal tunnel syndrome. [2020]