Diabetic Neuropathy, PainfulNCT06152887
Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain
A study testing Sooma Oy (tDCS), Helsinki, Finland in people with Diabetic Neuropathy, Painful and Diabetes Mellitus, Type 1, run by Jens Brøndum Frøkjær at 1 site in Denmark.
Trial summary
To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Neuropathy, Painful, Diabetes Mellitus, Type 1
- What is being tested?
- Sooma Oy (tDCS), Helsinki, Finland
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years.
- Type-1 diabetes
- Clinically established peripheral neuropathy
- DN4 of ≥4 points indicating that the patient is suffering from neuropathic pain.
- NRS pain scores >3
- Acceptable screening blood samples according to medical judgement
- Signed informed consent
Who cannot join
- Contraindications to MRI
- Not being able to understand Danish (written and/or verbally)
- Not being able to comply with the study procedures including home-treatment e.g., due to senile dementia, etc.
- Previous brain surgery
- Present alcohol or drug abuse
- Major mental and psychiatric disorders
Show all 12Show fewer
- Pregnancy
- Active cancer-disease
- Known neural damage or disease in the neural system (e.g., MS or Guillain-Barre) other than diabetic neuropathy
- Previous chemotherapy or intake of experimental medicine
- Active herpes simplex virus or varicella zoster virus infection or known HIV
- Other reasons for limb pain (e.g., critical limb ischemia and lower back pain with radiating pain etc.)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Jens Brøndum Frøkjær, MD, PhD, 97 66 51 05, jebf@rn.dk
Janusiya Anajan, M.Sc, PhD, 97 66 51 19, jebf@rn.dk
About this study
Official title: Treatment of Pain and Sensory Dysfunction in Diabetic Neuropathy by Brain Neuromodulation
To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment.
Read the detailed description
This study is a randomized, cross-over, controlled investigation. The overall objective of this study is to assess the pain-relieving effect of four weeks' transcranial direct current stimulation (tDCS) in individuals with type 1 diabetes and painful polyneuropathy not responding adequately to traditional pharmacological pain treatment, in comparison to the effect of four weeks' sham treatment. Both treatments will be performed using a commercially available and validated device called Sooma tDCS. Sooma tDCS device is a non-invasive neurostimulator that has been CE-marked for the treatment of depression, chronic pain including neuropathic pain and fibromyalgia. The study will begin with a 2-week baseline registration period, in which the patients will receive no treatment. Next, the baseline period will be followed by a 4-week treatment period where the subjects will be randomized to either active treatment or sham treatment. Afterwards, a wash-out period of 6 weeks will occur. Finally, in the second treatment period the patients will switch in treatment assignment, meaning that patient who received active treatment will now receive sham treatment and vice versa. During both treatments, the patients will be asked to self-administer one stimulation dose daily, five times a week. During the whole study, subjects will be asked to complete a pain diary and several questionnaires. Moreover, at the beginning and end of each treatment period (four times), all subjects will undergo testing which will include brain magnetic resonance imaging (MRI) and quantitative sensory testing (QST). The primary efficacy parameters to be evaluated are short and longer lasting alleviation of clinical chronic pain and quality of life.
- Being tested
- Sooma Oy (tDCS), Helsinki, Finland, Sooma Oy (Sham), Helsinki, Finland
- Keywords
- tDCS treatment, noninvasive cortical stimulation
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sooma Oy (tDCS), Helsinki, FinlandDevice
Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1)
Sooma Oy (Sham), Helsinki, FinlandDevice
For the sham treatment, an electrical current will also be increased from 0 mA to 2 mA over the first 30 seconds, however, the current will be ramped back down to 0 mA after the initial ramp-up phase and no stimulation is delivered for the rest of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCs | Active comparator | Active tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator. An anodal electrode is placed above the primary motor cortex, M1, while a cathode is placed above the contralateral supraorbital area. Receives: Device: Sooma Oy (tDCS), Helsinki, Finland |
| Sham tDCS | Sham comparator | Sham stimulation will be delivered to the motor cortex using a sham tDCS device that delivers a direct current for 30 seconds at the beginning and end of tDCS to provide sensory experiences similar to active stimulation. Receives: Device: Sooma Oy (Sham), Helsinki, Finland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numeric rating scale (NRS) scores in pain diary
The primary clinical efficacy parameter to be evaluated is pain relief. In the clinical part of the study the efficacy is assessed as changes in the daily experience of pain, which will be measured using a patient pain diary based on the NRS. Maximum intensity and average daily NRS will be recorded on daily basis.
Minimum: 0 Maximum: 10
Measured: 20 weeks
Secondary outcomes (5)
Brief Pain Inventory questionnaire (mBPI)
Measured: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Neuropathy Total Symptom Score-6 (NTSS-6)
A score >0 indicates the presence of >1 sensory symptom. Clinically significant symptoms are defined as an NTSS-6 total score >6 points.
Measured: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Hospital Anxiety and Depression Scale (HADS)
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Measured: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Brain MRI
Resting state functional MRI will be employed to detect brain activity and functional connectivity changes based on BOLD signals before and after treatment of each patient.
Measured: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Quantitative sensory testing
QST includes temporal summation, pressure pain thresholds, and conditioned pain modulation (CPM).
Measured: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Brøndum Frøkjær
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Vissing fonden
- Responsible party
- Sponsor-investigator, Jens Brøndum Frøkjær, Aalborg University Hospital
- Investigators
- Jens Brøndum Frøkjær, MD, Ph.D, Principal investigator, Professor and Chief Physician at Aalborg University Hospital, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152887
- Sponsor's protocol ID
- NOPAIN study
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muthulingam JA, Lyng AB, Hostrup SN, Ejskjaer N, Roikjer J, Brock C, Drewes AM, Frokjaer JB. Home-Based Transcranial Direct Current Stimulation in Painful Diabetic Peripheral Neuropathy: A Double Blinded, Randomized, Low-Intensity Sham-Controlled Crossover Trial. Neuromodulation. 2026 Jul 1:S1094-7159(26)00628-8. doi: 10.1016/j.neurom.2026.06.467. Online ahead of print.
PubMed 42606402
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pain and Sensory Dysfunction in Diabetic Neuropathy by Brain Neuromodulation
- ClinicalTrials.gov ID
- NCT06152887
- Acronym / sponsor ID
- NOPAIN study
- Keywords
- tDCS treatment, noninvasive cortical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jens Brøndum FrøkjærUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Vissing fonden
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Dec 2023 (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.
To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment.
Detailed description
This study is a randomized, cross-over, controlled investigation. The overall objective of this study is to assess the pain-relieving effect of four weeks' transcranial direct current stimulation (tDCS) in individuals with type 1 diabetes and painful polyneuropathy not responding adequately to traditional pharmacological pain treatment, in comparison to the effect of four weeks' sham treatment. Both treatments will be performed using a commercially available and validated device called Sooma tDCS. Sooma tDCS device is a non-invasive neurostimulator that has been CE-marked for the treatment of depression, chronic pain including neuropathic pain and fibromyalgia. The study will begin with a 2-week baseline registration period, in which the patients will receive no treatment. Next, the baseline period will be followed by a 4-week treatment period where the subjects will be randomized to either active treatment or sham treatment. Afterwards, a wash-out period of 6 weeks will occur. Finally, in the second treatment period the patients will switch in treatment assignment, meaning that patient who received active treatment will now receive sham treatment and vice versa. During both treatments, the patients will be asked to self-administer one stimulation dose daily, five times a week. During the whole study, subjects will be asked to complete a pain diary and several questionnaires. Moreover, at the beginning and end of each treatment period (four times), all subjects will undergo testing which will include brain magnetic resonance imaging (MRI) and quantitative sensory testing (QST). The primary efficacy parameters to be evaluated are short and longer lasting alleviation of clinical chronic pain and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCs | Active comparator | Device: Sooma Oy (tDCS), Helsinki, FinlandActive tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator. An anodal electrode is placed above the primary motor cortex, M1, while a cathode is placed above the contralateral supraorbital area. |
| Sham tDCS | Sham comparator | Device: Sooma Oy (Sham), Helsinki, FinlandSham stimulation will be delivered to the motor cortex using a sham tDCS device that delivers a direct current for 30 seconds at the beginning and end of tDCS to provide sensory experiences similar to active stimulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum age of 18 years.
- Type-1 diabetes
- Clinically established peripheral neuropathy
- DN4 of ≥4 points indicating that the patient is suffering from neuropathic pain.
- NRS pain scores >3
Key exclusion criteria (12 listed)
- Contraindications to MRI
- Not being able to understand Danish (written and/or verbally)
- Not being able to comply with the study procedures including home-treatment e.g., due to senile dementia, etc.
- Previous brain surgery
- Present alcohol or drug abuse
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 |
|---|---|---|
| Sooma Oy (tDCS), Helsinki, FinlandUsing the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1) | Device | Active tDCs |
| Sooma Oy (Sham), Helsinki, FinlandFor the sham treatment, an electrical current will also be increased from 0 mA to 2 mA over the first 30 seconds, however, the current will be ramped back down to 0 mA after the initial ramp-up phase and no stimulation is delivered for the rest of the treatment. | Device | Sham tDCS |
Primary outcome
Change in numeric rating scale (NRS) scores in pain diary
Time frame: 20 weeks
The primary clinical efficacy parameter to be evaluated is pain relief. In the clinical part of the study the efficacy is assessed as changes in the daily experience of pain, which will be measured using a patient pain diary based on the NRS. Maximum intensity and average daily NRS will be recorded on daily basis. Minimum: 0 Maximum: 10
5 secondary outcomes
Brief Pain Inventory questionnaire (mBPI)
Time frame: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Neuropathy Total Symptom Score-6 (NTSS-6)
Time frame: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Brain MRI
Time frame: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Quantitative sensory testing
Time frame: Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 42606402Muthulingam JA, Lyng AB, Hostrup SN, Ejskjaer N, Roikjer J, Brock C, Drewes AM, Frokjaer JB. Home-Based Transcranial Direct Current Stimulation in Painful Diabetic Peripheral Neuropathy: A Double Blinded, Randomized, Low-Intensity Sham-Controlled Crossover Trial. Neuromodulation. 2026 Jul 1:S1094-7159(26)00628-8. doi: 10.1016/j.neurom.2026.06.467. Online ahead of print.
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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. This study is not recruiting at the moment.
Jens Brøndum Frøkjær, MD, Ph.D principal investigator
Professor and Chief Physician at Aalborg University Hospital, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sooma Oy (tDCS), Helsinki, Finland in people with Diabetic Neuropathy, Painful and Diabetes Mellitus, Type 1, run by Jens Brøndum Frøkjær at 1 site in Denmark.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Brøndum Frøkjær, MD, Ph.D (9766 5105 ext. +45, jebf@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in numeric rating scale (NRS) scores in pain diary (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152887, which also lists 1 linked publication.
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 1 Dec 2023.