Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Status
Completed
Conditions
Incomplete Spinal Cord Injury
Treatments
Device: Cathodal tsDCS
Device: Anodal tsDCS
Device: Sham tsDCS
Details and patient eligibility
About
The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI).
Full description
The purpose of the study is to investigate the effects of a novel therapeutic approach to promote functional recovery and spasticity in chronic SCI. The tsDCS effect on neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil be evaluated in subjects with SCI. This incremental, design will allow the establishment of strong electrophysiological data prior to rapid clinical translation of the findings about this promising, early-stage technique.
The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in SSEP amplitude and latency, in a polarity dependent manner.
Enrollment
15 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Providing written informed consent prior to any study related procedures
- 18-65 years of age
- Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS)
- Traumatic lesion at or above T8-T9 neurological level
- Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks guiding stimulation);
- Chronic SCI (time since injury>6 months)
Exclusion criteria
- Unstable cardiopulmonary conditions
- History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
- Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4
- Subject who cannot provide self-transportation to the study location
- Cardiac or neural pacemakers
- Pregnancy
- lower motor neuron injury (eg: peripheral neuropathy, cauda equina syndrome)
- Uncontrolled diabetes with HbA1C>7
- History of severe autonomic dysreflexia
- No planned alteration in therapy or medication for muscle tone during the course of the study(No botulinum toxin injections in last 3 months, No phenol injections in last 6 months, intrathecal baclofen pump dose stable for past 3 months, etc)
- Conditions for e.g., severe arthritis, extreme shoulder pain that would interfere with valid administration of the measures or with interpreting motor testing;
- No contraindications to tsDCS
- ferromagnetic material in the brain or in the spine (except for titanium used in segmental)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Triple Blind
15 participants in 11 patient groups
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
Experimental group
Description:
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
Treatment:
Device: Anodal tsDCS
Device: Sham tsDCS
Device: Cathodal tsDCS
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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