Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000240943
Ethics application status
Approved
Date submitted
4/01/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of multi-target transcranial current stimulation on cognition and pain.
Scientific title
Effect of non-invasive single- versus multi-target high definition transcranial current stimulation on cognitive functioning and experimental pain measures in healthy adults – A pilot randomised controlled trial.
Secondary ID [1] 300173 0
None
Universal Trial Number (UTN)
U1111-1242-2395
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 315719 0
Cognitive function 315720 0
Condition category
Condition code
Neurological 314006 314006 0 0
Studies of the normal brain and nervous system
Mental Health 314237 314237 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial current stimulation will be administered for a single session of 30 minutes duration using a 32 channel transcranial current stimulator (Starstim32 TCS®, Neuroelectrics, Spain), by a researcher experienced in neuromodulation techniques. For the active treatment group, the stimulation will be delivered (through 12 electrodes placed on the scalp) at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between.
Intervention code [1] 316457 0
Treatment: Devices
Comparator / control treatment
Sham stimulation group: to create an identical skin sensation to the active stimulation, the current will be applied for a 60s ramp up (0-2mA) and 60s ramp down (2-0mA) at the beginning and the end of each stimulation session, without any current for the remainder of the stimulation period.
Control group
Placebo

Outcomes
Primary outcome [1] 322416 0
Presence of any adverse events (e.g. itching, headache, fatigue). The severity of each symptom will be rated on a VAS scale.
Timepoint [1] 322416 0
Immediately before and after intervention
Primary outcome [2] 322623 0
Neurocognitive tests (executive function, working memory) : Stroop task, Trail Making Test, Digit Span test
Timepoint [2] 322623 0
Immediately before and after intervention
Primary outcome [3] 322624 0
Mechanical temporal summation: MTS will be assessed using a nylon monofilament (Semmes monofilament 6.65, 300 g). Brief ten repetitive contacts will be delivered at a rate of 1 Hz, externally cued by auditory stimuli. The participants will be asked to rate the level of pain experienced on the 11 point numeric pain rating scale (NPRS, 0=No pain to 100=Extreme pain) immediately after the first contact, and also to rate their greatest pain intensity after the 10th contact. Three trials will be conducted at the non-dominant wrist joint, and the average will be used for analysis.
Timepoint [3] 322624 0
Immediately before and after intervention
Secondary outcome [1] 378396 0
Electroencephalography patterns (whole brain activity and functional connectivity)
Timepoint [1] 378396 0
Immediately before and after intervention
Secondary outcome [2] 379951 0
Conditioned pain modulation procedure (CPM): This involves recording pressure to pain threshold over the non-dominant leg region (Tibialis anterior muscle) before and after the application of a conditioning stimulus (immersion of dominant hand, in a cold bath for a maximum of two minutes; maintained at ~5 degrees). A percent change score will be calculated.
Timepoint [2] 379951 0
Immediately before and after intervention
Secondary outcome [3] 379952 0
Change in the pressure to pain threshold (PPT) (KPa): A computerised, handheld digital algometer (AlgoMed; Medoc, Ramat Yishai, Israel) will be used to measure three trials of PPT over the non-dominant wrist, and the average of three trials will be used for analysis.
Timepoint [3] 379952 0
Immediately before and after intervention

Eligibility
Key inclusion criteria
To be included in the study, participants must meet all of the following inclusion criteria:
• Capable of understanding and signing an informed consent form
• Cognitively healthy, as determined by age norms of Mini Mental Status Examination
• Age between 35 to 75 years on the day of the consent and
• Right dominant
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of the following conditions will be excluded:
• History of neurological disease
• History of epileptic seizures
• Unstable medical or psychiatric conditions
• Presence of any pacemaker or defibrillator
• Presence of any implant in head/neck
• Presence of any pain/ related condition
• Alcohol or substance abuse
• Presence of any peripheral neuropathy or vascular pathology

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/01/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
80
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 22200 0
New Zealand
State/province [1] 22200 0
Otago

Funding & Sponsors
Funding source category [1] 304612 0
University
Name [1] 304612 0
University of Otago
Country [1] 304612 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, North Dunedin, Dunedin 9016, New Zealand
Country
New Zealand
Secondary sponsor category [1] 304905 0
None
Name [1] 304905 0
NA
Address [1] 304905 0
NA
Country [1] 304905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305033 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305033 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 305033 0
New Zealand
Date submitted for ethics approval [1] 305033 0
Approval date [1] 305033 0
20/12/2019
Ethics approval number [1] 305033 0

Summary
Brief summary
The purpose of this study is to explore the effect of a non-invasive external brain stimulation technique [Transcranial current stimulation (TCS)] on cognitive functioning (e.g. memory, attention) and experimental pain measures (e.g. sensitivity to pressure/pain sensation) in healthy middle-aged and older adults. Different regions of our brain work together synchronously, such that certain regions of the brain are activated and others are deactivated based on a particular task. This study will compare the effects of stimulating a single brain region versus simultaneously stimulating two brain regions, on cognitive functioning and experimental pain measures. The findings from this study will help us determine if simultaneously targeting different brain regions can improve cognitive functioning and pain measures.

The brain regions targeted in the current study have demonstrated to be altered in several neurological and neuropsychiatric conditions (e.g. Alzheimer’s disease, traumatic brain injury, schizophrenia, chronic pain, attention deficit hyperactivity disorder, multiple sclerosis, and Parkinson’s disease). The TCS technique has considerable potential as a treatment for these disorders due to its relatively low cost, safety, portability, and ease of use compared with other methods. This study will thus help us establish safety and efficacy of the proposed stimulation technique and will enable us to develop novel interventions to improve health outcomes in various (above mentioned) clinical conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99042 0
Dr Divya Adhia
Address 99042 0
DEPARTMENT OF SURGICAL SCIENCES
DUNEDIN SCHOOL OF MEDICINE
University of Otago
PO Box 56,
Dunedin 9054,
New Zealand
Country 99042 0
New Zealand
Phone 99042 0
+64 3 470 9337
Fax 99042 0
Email 99042 0
[email protected]
Contact person for public queries
Name 99043 0
Divya Adhia
Address 99043 0
DEPARTMENT OF SURGICAL SCIENCES
DUNEDIN SCHOOL OF MEDICINE
University of Otago
PO Box 56,
Dunedin 9054,
New Zealand
Country 99043 0
New Zealand
Phone 99043 0
+64 3 470 9337
Fax 99043 0
Email 99043 0
[email protected]
Contact person for scientific queries
Name 99044 0
Divya Adhia
Address 99044 0
DEPARTMENT OF SURGICAL SCIENCES
DUNEDIN SCHOOL OF MEDICINE
University of Otago
PO Box 56,
Dunedin 9054,
New Zealand
Country 99044 0
New Zealand
Phone 99044 0
+64 3 470 9337
Fax 99044 0
Email 99044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.