Diabetic Peripheral Neuropathy (DPN)NCT07905729
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
A study testing Transcranial Direct Current Stimulation (tDCS) and Transcranial Alternating Current Stimulation (tACS) in people with Diabetic Peripheral Neuropathy (DPN), run by University of Management and Technology Lahore at 1 site in Pakistan.
Trial summary
This study will be to compare the effects of transcranial direct current stimulation and transcranial alternating current stimulation on neuropathic pain, manual dexterity and isometric muscle strength in diabetic peripheral neuropathic patients. Study design will be randomized clinical trial. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Transcranial Alternating Current Stimulation (tACS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 70 years ,
- Both Gender male and female
- HbA1c (>6.5%)
- Neuropathic symptoms, Diabetic Neuropathic Questionnaire (DN-4= >4)
- Visual Analogue Scale VAS (4 or higher)
- Stable chronic pain for at least 3 preceding months.
- Persistent pain after taking medications, such as non-steroidal anti-inflammatory drugs, tramadol, antidepressants, antiepileptic drugs, or opioids.
- Mini Mental Status Examination MMSE (>24)
Who cannot join
- Any uncontrolled clinical disease (as evaluated by each patient's clinician), such as thyroid, cardiovascular, pulmonary, haematological, pulmonary, or renal disease or psychiatric disorder
- history of substance abuse or neuropsychiatric comorbidity
- implanted devices for pain control, such as vagal or deep brain stimulators
- Pain attributable to other causes, such as spinal stenosis, peripheral blood vessel disease, lower extremity edema-related pain, and neuropathic pain due to a brain lesion or peripheral nerve injury,
- Contraindication for tDCS, such as an intracranial or orbital metallic implant or pacemaker
- alcoholism
- dizziness and amputation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Management & Technology
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects of Transcranial Direct Current Stimulation and Transcranial Alternating Current Stimulation on Neuropathic Pain, Manual Dexterity and Strength in Diabetic Peripheral Neuropathic Patients.
This study will be to compare the effects of transcranial direct current stimulation and transcranial alternating current stimulation on neuropathic pain, manual dexterity and isometric muscle strength in diabetic peripheral neuropathic patients. Study design will be randomized clinical trial. Evaluation will be done by using McGill Pain Questionnaire-2, Digital force gauge sf-500 and wooden 9 hole peg board. Non-probability convenient sampling will be used and 38 subjects will be allocated to two groups by random allocation. Group A will receive TDCS and Group B will receive TACS. Both groups will receive hot pack, and ROM exercises of upper extremity before techniques application. Both groups will receive 20 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline and 4th week.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS)
- Keywords
- Transcranial direct current stimulation, Transcranial alternating current stimulation, neuropathic pain, muscle strength, Diabetic Neuropathy
- Medical subject headings
- Neuralgia, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Other
Transcranial Direct Current Stimulation (tDCS) will be applied over the primary motor cortex (M1) hand area corresponding to the C3 position according to the International 10-20 EEG system. The anodal electrode will be positioned over C3, while the cathodal electrode will be placed over the right supraorbital region. Saline-soaked sponge electrodes measuring 5 × 5 cm will be used for stimulation. A direct current of 2 mA will be delivered for 20 minutes per session. The intervention will be administered once daily, five days per week, for a total of 20 sessions over a period of 4 weeks.
Transcranial Alternating Current Stimulation (tACS)Other
Transcranial Alternating Current Stimulation (tACS) will be applied targeting the frontal cortex and the primary motor cortex (M1). Stimulation will be delivered at an intensity of 2 mA with a frequency of 5 -10 Hz bilaterally. Each treatment session will last 20 minutes. The intervention will be administered daily for five days per week according to the treatment schedule. Standardized electrode placement and stimulation parameters will be maintained throughout the intervention period to ensure consistency across sessions.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) with Conventional Physical Therapy | Experimental | Transcranial Direct Current Stimulation (tDCS) will be applied over the primary motor cortex (M1) hand area corresponding to the C3 position according to the International 10-20 EEG system. The anodal electrode will be positioned over C3, while the cathodal electrode will be placed over the right supraorbital region. Saline-soaked sponge electrodes measuring 5 × 5 cm will be used for stimulation. A direct current of 2 mA will be delivered for 20 minutes per session. The intervention will be administered once daily, five days per week, for a total of 20 sessions over a period of 4 weeks Receives: Other: Transcranial Direct Current Stimulation (tDCS) |
| Transcranial Alternating Current Stimulation (tACS) with Conventional Physical Therapy | Active comparator | Transcranial Alternating Current Stimulation (tACS) will be applied targeting the frontal cortex and the primary motor cortex (M1). Stimulation will be delivered at an intensity of 2 mA with a frequency of 5 -10 Hz bilaterally. Each treatment session will last 20 minutes. The intervention will be administered daily for five days per week according to the treatment schedule. Standardized electrode placement and stimulation parameters will be maintained throughout the intervention period to ensure consistency across sessions Receives: Other: Transcranial Alternating Current Stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain by McGill Pain Questionnaire-2
The MPQ-2 is a self-report questionnaire designed to evaluate different dimensions of pain, including continuous, intermittent, neuropathic, and affective pain descriptors. The questionnaire consists of 22 pain descriptors, each rated on an 11-point numerical scale ranging from 0 (none) to 10 (worst possible).
Measured: at baseline and after 4th week
Isometric Muscle Strength by digital force gauge SF-500
It will measure muscle groups such as shoulder flexors, extensors, abductors, adductors, elbow flexors and extensors, wrist flexors and extensors in Kg. Before the test, a standard instruction of "push as hard as you can" will give, and during the test, the patients will be encourage to apply maximal effort. Maximal strength will exerted for 3 to 5 seconds, at which point the examiner instructed the person to relax. Maximal isometric muscle strength will recorded for all measured upper-extremity muscle groups
Measured: at baseline and after 4th week
Manual Dexterity by Wooden 9 hole peg test
The NHPT consists of a rectangular base and 9 pegs (7 mm in diameter, 32 mm in length). The base is divided into two parts; the container is located where the pegs will be housed in one, while a pegboard composed of 9 holes (10 mm in diameter, 15 mm deep) in which each of the pegs will be inserted is in the other. The pegboard will centered in front of the subject with the container side on the same side as the hand being tested. The dominant hand will tested first. Subjects completed one practice trial followed by the actual timed test for each hand
Measured: at baseline and after 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start22 Oct 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Management and Technology Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Hassan, University of Management and Technology Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905729
- Sponsor's protocol ID
- RE-204-2026
- Status last verified
- Nov 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results data collected , de-identified individual participant data will be shared.
Publications
Hu K, Wan R, Liu Y, Niu M, Guo J, Guo F. Effects of transcranial alternating current stimulation on motor performance and motor learning for healthy individuals: A systematic review and meta-analysis. Front Physiol. 2022 Nov 18;13:1064584. doi: 10.3389/fphys.2022.1064584. eCollection 2022.
PubMed 36467691Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.
PubMed 24466511
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Transcranial Direct Current Stimulation and Transcranial Alternating Current Stimulation on Neuropathic Pain, Manual Dexterity and Strength in Diabetic Peripheral Neuropathic Patients.
- ClinicalTrials.gov ID
- NCT07905729
- Acronym / sponsor ID
- RE-204-2026
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Transcranial direct current stimulation, Transcranial alternating current stimulation, neuropathic pain, muscle strength, Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Management and Technology LahoreUniversity, hospital or other
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Oct 2026 (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.
This study will be to compare the effects of transcranial direct current stimulation and transcranial alternating current stimulation on neuropathic pain, manual dexterity and isometric muscle strength in diabetic peripheral neuropathic patients. Study design will be randomized clinical trial. Evaluation will be done by using McGill Pain Questionnaire-2, Digital force gauge sf-500 and wooden 9 hole peg board. Non-probability convenient sampling will be used and 38 subjects will be allocated to two groups by random allocation. Group A will receive TDCS and Group B will receive TACS. Both groups will receive hot pack, and ROM exercises of upper extremity before techniques application. Both groups will receive 20 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline and 4th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) with Conventional Physical Therapy | Experimental | Other: Transcranial Direct Current Stimulation (tDCS)Transcranial Direct Current Stimulation (tDCS) will be applied over the primary motor cortex (M1) hand area corresponding to the C3 position according to the International 10-20 EEG system. The anodal electrode will be positioned over C3, while the cathodal electrode will be placed over the right supraorbital region. Saline-soaked sponge electrodes measuring 5 × 5 cm will be used for stimulation. A direct current of 2 mA will be delivered for 20 minutes per session. The intervention will be administered once daily, five days per week, for a total of 20 sessions over a period of 4 weeks |
| Transcranial Alternating Current Stimulation (tACS) with Conventional Physical Therapy | Active comparator | Other: Transcranial Alternating Current Stimulation (tACS)Transcranial Alternating Current Stimulation (tACS) will be applied targeting the frontal cortex and the primary motor cortex (M1). Stimulation will be delivered at an intensity of 2 mA with a frequency of 5 -10 Hz bilaterally. Each treatment session will last 20 minutes. The intervention will be administered daily for five days per week according to the treatment schedule. Standardized electrode placement and stimulation parameters will be maintained throughout the intervention period to ensure consistency across sessions |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 45 to 70 years ,
- Both Gender male and female
- HbA1c (>6.5%)
- Neuropathic symptoms, Diabetic Neuropathic Questionnaire (DN-4= >4)
- Visual Analogue Scale VAS (4 or higher)
Key exclusion criteria (7 listed)
- Any uncontrolled clinical disease (as evaluated by each patient's clinician), such as thyroid, cardiovascular, pulmonary, haematological, pulmonary, or renal disease or psychiatric disorder
- history of substance abuse or neuropsychiatric comorbidity
- implanted devices for pain control, such as vagal or deep brain stimulators
- Pain attributable to other causes, such as spinal stenosis, peripheral blood vessel disease, lower extremity edema-related pain, and neuropathic pain due to a brain lesion or peripheral nerve injury,
- Contraindication for tDCS, such as an intracranial or orbital metallic implant or pacemaker
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Transcranial Direct Current Stimulation (tDCS) will be applied over the primary motor cortex (M1) hand area corresponding to the C3 position according to the International 10-20 EEG system. The anodal electrode will be positioned over C3, while the cathodal electrode will be placed over the right supraorbital region. Saline-soaked sponge electrodes measuring 5 × 5 cm will be used for stimulation. A direct current of 2 mA will be delivered for 20 minutes per session. The intervention will be administered once daily, five days per week, for a total of 20 sessions over a period of 4 weeks. | Other | Transcranial Direct Current Stimulation (tDCS) with Conventional Physical Therapy |
| Transcranial Alternating Current Stimulation (tACS)Transcranial Alternating Current Stimulation (tACS) will be applied targeting the frontal cortex and the primary motor cortex (M1). Stimulation will be delivered at an intensity of 2 mA with a frequency of 5 -10 Hz bilaterally. Each treatment session will last 20 minutes. The intervention will be administered daily for five days per week according to the treatment schedule. Standardized electrode placement and stimulation parameters will be maintained throughout the intervention period to ensure consistency across sessions. | Other | Transcranial Alternating Current Stimulation (tACS) with Conventional Physical Therapy |
Primary outcome
Pain by McGill Pain Questionnaire-2
Time frame: at baseline and after 4th week
The MPQ-2 is a self-report questionnaire designed to evaluate different dimensions of pain, including continuous, intermittent, neuropathic, and affective pain descriptors. The questionnaire consists of 22 pain descriptors, each rated on an 11-point numerical scale ranging from 0 (none) to 10 (worst possible).
Isometric Muscle Strength by digital force gauge SF-500
Time frame: at baseline and after 4th week
It will measure muscle groups such as shoulder flexors, extensors, abductors, adductors, elbow flexors and extensors, wrist flexors and extensors in Kg. Before the test, a standard instruction of "push as hard as you can" will give, and during the test, the patients will be encourage to apply maximal effort. Maximal strength will exerted for 3 to 5 seconds, at which point the examiner instructed the person to relax. Maximal isometric muscle strength will recorded for all measured upper-extremity muscle groups
Manual Dexterity by Wooden 9 hole peg test
Time frame: at baseline and after 4th week
The NHPT consists of a rectangular base and 9 pegs (7 mm in diameter, 32 mm in length). The base is divided into two parts; the container is located where the pegs will be housed in one, while a pegboard composed of 9 holes (10 mm in diameter, 15 mm deep) in which each of the pegs will be inserted is in the other. The pegboard will centered in front of the subject with the container side on the same side as the hand being tested. The dominant hand will tested first. Subjects completed one practice trial followed by the actual timed test for each hand
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 36467691Hu K, Wan R, Liu Y, Niu M, Guo J, Guo F. Effects of transcranial alternating current stimulation on motor performance and motor learning for healthy individuals: A systematic review and meta-analysis. Front Physiol. 2022 Nov 18;13:1064584. doi: 10.3389/fphys.2022.1064584. eCollection 2022.
- Background: PubMed 24466511Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results data collected , de-identified individual participant data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Transcranial Alternating Current Stimulation (tACS) in people with Diabetic Peripheral Neuropathy (DPN), run by University of Management and Technology Lahore at 1 site in Pakistan.
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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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 Pakistan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain by McGill Pain Questionnaire-2 (time frame: at baseline and after 4th week). The study lists 3 primary outcomes in all. 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 NCT07905729, which also lists 2 linked publications.
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 3 Nov 2026.